Total 14 job vacancies by No Deviation Pte. Ltd.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Maintenance Equipment Engineer is responsible for ensuring the reliability, availability, and compliance of manufacturing equipment within the API plant. This role supports maintenance strategies, troubleshooting, and continuous improvement to ensure safe, efficient, and GMP-compliant operations.

Key Responsibilities

1. Equipment Reliability & Maintenance

• Develop and implement preventive and predictive maintenance programs for API manufacturing equipment
• Ensure high equipment uptime and reliability to support production targets
• Troubleshoot and resolve equipment breakdowns in a timely manner

2. Maintenance Strategy & Optimization

• Drive continuous improvement initiatives to enhance equipment performance (MTBF, MTTR)
• Support root cause analysis (RCA) and implement corrective and preventive actions (CAPA)
• Optimize maintenance plans based on data, equipment history, and criticality

3. GMP Compliance & Documentation

• Ensure all maintenance activities comply with cGMP, EHS, and internal quality standards
• Maintain accurate documentation including maintenance records, SOPs, and logbooks
• Support audit readiness and regulatory inspections (e.g., FDA, EMA)

4. Equipment Support & Technical Expertise

• Provide technical support for process equipment
• Liaise with equipment vendors and contractors for maintenance, repair, and upgrades
• Support commissioning, qualification (IQ/OQ/PQ), and validation activities

5. Cross-functional Collaboration

• Work closely with Production, Engineering, QA, and Validation teams
• Support deviation investigations related to equipment failures
• Participate in cross-functional projects for process improvement and plant upgrades

6. Project & Change Management

• Support or lead engineering projects related to equipment upgrades, replacements, and modifications
• Manage change control processes in compliance with GMP requirements
• Ensure timely execution of maintenance-related CAPEX and improvement projects

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or related discipline
• 3–8 years of experience in pharmaceutical, API, or chemical manufacturing environment
• Strong understanding of GMP requirements and regulated industry standards
• Experience in maintenance of process equipment in API manufacturing

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking a Utilities Engineer to ensure the proper maintenance and compliance of facility systems and equipment according to design specifications and GMP standards. The engineer will provide technical expertise for the operation and maintenance of utilities systems, supporting routine operations readiness. Responsibilities include ensuring adherence to standards, supporting the development of commissioning and qualification documents, and ensuring compliance with regulatory requirements. The role also involves troubleshooting technical issues, collaborating with cross-functional teams, and promoting knowledge sharing.

Key Responsibilities

Operational Excellence, Continuous Improvement, and Daily Operations

• Lead and support continuous improvement initiatives for utility system operations, maintenance, and reliability programs.
• Establish key metrics to ensure optimal performance of utility operations.
• Lead and support utility projects by reviewing engineering design documentation and related drawings.
• Lead and support Site Acceptance Tests (SAT), commissioning, and system testing to meet User Requirement Specifications (URS).
• Participate in system walk-downs to ensure reliable utility system operations.
  

Safety and Quality Compliance Management

• Lead and support audit readiness activities for regulatory inspections to ensure compliance with site and global SOPs, GEP, and GDP requirements.
• Assist in the development, revision, review, and approval of Standard Operating Procedures (SOPs), Risk Assessments, Preventive Maintenance Programs, and Job Plans.
• Lead and support deviation investigations, ensuring appropriate Corrective and Preventive Actions (CAPA) are implemented.
• Lead and support change control activities and continuous improvement initiatives to enhance system reliability and operational performance.
• Actively promote and uphold the Company's Safety Culture.

Sustainability

• Lead and support site sustainability initiatives through analysis of utility and energy consumption data.
• Identify opportunities to optimize utility usage and improve energy efficiency.
• Support the development of business cases and proposals to achieve site sustainability objectives.
• Generate and compile utility consumption data for regulatory authority submissions and internal reporting.

Required Qualifications

• Diploma or Degree in Mechanical, Electrical, Chemical, or related Engineering disciplines.
• Ability to work independently and collaboratively within cross-functional teams.
• Strong interpersonal, communication, and presentation skills.
• Proficient in computer applications and documentation systems.
• Experience working in a highly regulated environment with GMP documentation practices.
• Strong analytical and problem-solving capabilities with the ability to identify improvement opportunities.
• Effective stakeholder management and facilitation skills to achieve project and operational objectives.
• Ability to influence and collaborate positively with peers and stakeholders.
• Familiarity with utilities systems, maintenance programs, commissioning, qualification, and compliance requirements within pharmaceutical, biotech, or related manufacturing environments is preferred.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer with strong experience in aseptic and sterile manufacturing environments. The successful candidate will be responsible for executing CQV activities across equipment, utilities, and cleanroom systems, ensuring compliance with GMP and regulatory requirements.

Key Responsibilities

• Execute commissioning and qualification (IQ/OQ/PQ) activities for process equipment, clean utilities, and facilities in aseptic manufacturing areas.
• Develop, review, and approve validation protocols and reports in alignment with GMP, FDA, and EU regulatory requirements.
• Support aseptic processes, including cleanroom qualification, HVAC systems, and environmental monitoring (EM).
• Perform risk assessments (e.g., FMEA, impact assessments) to define validation strategies.
• Ensure compliance with sterility assurance requirements, including contamination control and aseptic processing guidelines.
• Collaborate with cross-functional teams (Engineering, QA, Production) to support project timelines and deliverables.
• Manage and support deviations, CAPA, and change controls related to CQV activities.
• Participate in FAT/SAT activities, ensuring systems meet user requirements specifications (URS).
• Support regulatory audits and inspections, providing documentation and technical justifications where required.
• Ensure all documentation is maintained in accordance with data integrity (ALCOA+) principles.

Required Qualifications

• Bachelor's Degree in Engineering, Life Sciences, or related discipline.
• Minimum 3–5 years of CQV experience within the pharmaceutical or biotechnology industry.
• Hands-on experience in aseptic or sterile manufacturing environments (e.g., fill-finish, cleanroom operations).
• Strong knowledge of GMP regulations, Annex 1, FDA guidelines, and validation lifecycle.
• Experience with clean utilities (WFI, clean steam, compressed gases) and HVAC systems.
• Familiar with EM programs, cleanroom classifications, and contamination control strategies.
• Proven experience in protocol writing and execution.
• Strong problem-solving skills and ability to handle deviations and investigations.
• Excellent communication and stakeholder management skills.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The QC Personnel will be responsible for supporting day-to-day Quality Control laboratory activities, including testing, documentation, method validation support, data review, and compliance with GMP requirements. The role requires hands-on experience with laboratory systems such as GLIMS, Veeva, and SAP, as well as experience in analytical method validation activities.

Key Responsibilities

• Perform routine QC testing for raw materials, intermediates, finished products, stability samples, and/or environmental monitoring samples, as applicable
• Execute laboratory testing in accordance with approved SOPs, test methods, specifications, and GMP requirements.
• Ensure all laboratory activities are completed accurately, timely, and in compliance with data integrity expectations.
• Support sample receipt, testing coordination, result entry, and laboratory documentation.
• Support analytical method validation, verification, transfer, and qualification activities.
  
• Execute validation protocols and document results in accordance with approved acceptance criteria.
  
• Assist in the preparation, review, and closure of method validation protocols, reports, deviations, and supporting documentation.
  
• Support troubleshooting of analytical methods and laboratory investigations where required.
• Use GLIMS for sample management, test assignment, result entry, and laboratory workflow tracking.
• Use Veeva for document management, SOP retrieval, document review, training, and quality records where applicable.
• Use SAP for material/sample-related transactions, inventory checks, batch information retrieval, or quality-related processes.
• Ensure proper documentation practices in line with ALCOA+ principles and GMP expectations.
• Support laboratory investigations, OOS/OOT investigations, deviations, CAPA, and change control activities.
• Ensure timely escalation of abnormal results, laboratory issues, equipment issues, or documentation discrepancies.
• Participate in internal audits, external inspections, and laboratory readiness activities.
• Maintain laboratory areas, equipment, reagents, standards, and records in an inspection-ready state
• Support calibration, maintenance, and qualification readiness of laboratory equipment.
• Assist in laboratory process improvements, system updates, and workflow optimization.
• Work closely with QA, Manufacturing, MSAT, Validation, and Supply Chain teams to support product release and compliance requirements.

Required Qualifications

• Diploma or Degree in Chemistry, Pharmaceutical Science, Biotechnology, Microbiology, Life Sciences, or related discipline.
• Minimum 2 to 5 years of QC laboratory experience in a pharmaceutical, biologics, medical device, or GMP-regulated environment.
• Experience with method validation, method verification, or method transfer is required.
• Hands-on experience with laboratory or quality systems such as GLIMS, Veeva, and SAP.
  
• Experience in QC testing, laboratory documentation, investigations, and GMP compliance.
• Familiar with GMP, GDP, data integrity, ALCOA+, and laboratory compliance requirements.
• Experience with analytical techniques such as HPLC, GC, UV, pH, conductivity, TOC, endotoxin, bioburden, sterility, or other QC methods will be advantageous.
• Able to execute and document method validation activities according to approved protocols.
• Comfortable working with electronic systems for sample tracking, document control, training, and material/batch-related transactions.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Planner will support project planning, scheduling, coordination, and progress tracking activities. This is a junior-level role suitable for candidates with basic planning experience or strong administrative/project coordination experience who are keen to develop into a project planning function.

The role will involve supporting the preparation and maintenance of project schedules, tracking key activities, coordinating updates from stakeholders, and ensuring project information is accurate and up to date.

Key Responsibilities

• Assist in developing, updating, and maintaining project schedules.
• Support the tracking of project milestones, deliverables, timelines, and dependencies.
• Coordinate with project teams to obtain progress updates and reflect them in the project schedule.
• Help identify potential schedule delays, gaps, or conflicting activities for escalation to the senior planner or project manager.
• Maintain planning trackers, action logs, lookahead schedules, and progress reports.
• Work closely with project managers, engineers, validation teams, vendors, and other stakeholders to support project execution.
• Assist in coordinating meetings, schedule reviews, and project update discussions.
• Follow up with team members on outstanding actions, deliverables, and timeline commitments.
• Support the consolidation of inputs from multiple workstreams into project planning documents
• Prepare and maintain project progress reports, dashboards, and status updates.
• Support the preparation of weekly or monthly project reports.
• Ensure project planning records, trackers, and schedules are properly maintained.
• Assist in documenting schedule changes, action items, risks, and key decisions.
• Use planning tools such as Microsoft Project, Primavera P6, Excel, Smartsheet, or other scheduling tools, depending on project requirements.
• Maintain trackers and reports using Microsoft Excel, PowerPoint, SharePoint, or other project management platforms.
• Support data entry, schedule updates, and basic analysis of project progress.
• Assist in tracking schedule risks, delays, dependencies, and critical activities.
• Highlight overdue tasks, upcoming deadlines, and potential bottlenecks.
• Support the project team in maintaining visibility of key project timelines and priorities.

Required Qualifications

• Diploma in Engineering, Science, or related discipline.
• 0 to 2 years of experience in project planning, project coordination, scheduling, engineering support, or administrative project support.
• Fresh graduates with strong interest in project planning may be considered.
• Experience in pharmaceutical, life sciences, construction, engineering, manufacturing, or project-based environments will be advantageous.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The CQV Engineer is responsible to support commissioning, qualification and validation activities for GMP process equipment and utilities in a pharmaceutical / biotechnology environment. Focus on equipment such as stainless steel vessels, CIP/SIP systems, thermal systems and related process utilities. Prepare, execute, review and close CQV documentation in line with GMP, GDP and project requirements.

Key Responsibilities

• Prepare and execute CQV documents, including: Commissioning protocols, IQ / OQ / PQ protocols, Test scripts, Qualification reports, Deviation reports, Traceability matrices
• Support qualification of stainless steel vessels, including: Mixing vessels, Holding tanks, Buffer / media preparation vessels, Process tanks, Product-contact equipment
• Perform Material of Construction checks for stainless steel equipment, including verification of: MOC certificates, Surface finish, Welding documentation, Passivation records, Product-contact parts, Gasket / seal materials
  
• Support CIP and SIP qualification, including: Cycle verification, Sprayball coverage checks, Flow / pressure / temperature verification, Conductivity checks, Hold time verification, Drainability checks, Sterilisation cycle assessment
• Support thermal mapping / temperature qualification activities for GMP equipment and systems.
• Execute qualification testing and document results in accordance with approved protocols.
• Use Kneat for protocol execution, review, comment resolution and document lifecycle management.
• Support FAT / SAT, commissioning walkdowns and system handover activities.
• Review vendor documents, drawings, P&IDs, datasheets, manuals and calibration records.
• Raise and support closure of deviations, punch items, non-conformities and qualification discrepancies.
• Work with QA, Engineering, Manufacturing, Automation, Vendors and Project teams to ensure timely CQV completion.
• Ensure all qualification activities comply with GMP, GDP, data integrity and site SOP requirements.

Required Qualifications

• Degree / Diploma in Engineering, Biotechnology, Pharmaceutical Science, Life Sciences or related discipline.
• 3 to 5 years of relevant CQV experience in pharmaceutical, biotech, biologics or GMP manufacturing environment.
• Hands-on experience with CIP, SIP, thermal mapping and stainless steel process equipment.
• Experience performing Material of Construction checks for GMP equipment.
• Familiar with IQ / OQ / PQ execution and GMP documentation requirements.
• Experience using Kneat for validation document execution and review.
• Able to read and understand P&IDs, equipment drawings, datasheets and vendor technical documents.
• Good understanding of GMP, GDP, deviation management and change control.
• Strong documentation discipline and attention to detail.
• Able to work independently on site and coordinate with cross-functional teams.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.

Position Overview

We are looking for an Upstream Biotech personnel to support upstream biologics manufacturing activities in a GMP environment. The role will focus on cell culture operations, seed train expansion, bioreactor operations, media preparation, process monitoring, sampling, batch record execution, and GMP documentation.

The candidate should have hands-on experience in upstream biologics or biopharmaceutical manufacturing and be comfortable working in a GMP cleanroom environment.

Key Responsibilities

• Support daily upstream biologics manufacturing operations, including cell culture, seed train, inoculation, bioreactor operation, harvest, and related activities.
• Perform media preparation, filtration, transfer, and material handling in accordance with approved procedures.
• Operate upstream process equipment such as bioreactors, single-use systems, mixers, pumps, filters, and harvest equipment.
• Monitor process parameters such as pH, dissolved oxygen, temperature, agitation, gas flow, viable cell density, viability, osmolality, and metabolites.
• Perform in-process sampling and coordinate with QC for testing requirements.
• Execute production steps according to approved batch records, SOPs, GMP, and safety requirements.
• Complete GMP documentation accurately, including batch records, logbooks, equipment records, and cleaning records.
• Support basic troubleshooting of process or equipment issues during manufacturing operations.
• Support deviation reporting, investigation inputs, CAPA, and change control activities where required.
• Maintain manufacturing areas in a state of GMP readiness, including housekeeping, equipment status checks, material reconciliation, and cleanroom discipline.
• Work closely with Manufacturing, MSAT, QA, QC, Engineering, Automation, and Validation teams to ensure smooth production execution.
• Support facility start-up, process transfer, engineering runs, PPQ, or validation activities where required.

Required Qualifications

• Diploma / Degree in Biotechnology, Life Sciences, Bioprocess, Pharmaceutical Science, Chemical Process Technology, or related discipline.
• Minimum 1–5 years of relevant experience in upstream biologics manufacturing, cell culture, or biopharmaceutical production.
• Good understanding of GMP, GDP, aseptic practices, contamination control, and cleanroom behaviour.
• Experience with single-use bioreactors, wave bags, stainless-steel bioreactors, filtration systems, pumps, and automated manufacturing systems will be advantageous.
• Familiarity with DeltaV, MES, SCADA, electronic batch records, or LIMS will be an added advantage.
• Able to work independently and as part of a shift or manufacturing team.
• Willing to work in a GMP cleanroom environment and follow strict gowning requirements.
• Strong attention to detail and good documentation discipline

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

As a Process Technician, you will support plant operations by assisting with troubleshooting, process optimization, and monitoring processing parameters. Your duties include preparing solutions, staging components for autoclaving, and aiding in production sample testing. You will ensure compliance with GMP, EHS standards, and regulatory requirements, follow procedures, evaluate documentation, and contribute to safety audits while working with internal and external inspectors.

Key Responsibilities

• Play a key role in the hands-on execution of plant operations while providing valuable support to Manufacturing Associates in troubleshooting and resolving issues.
• Monitor and analyze processing parameters to identify trends and uncover opportunities for process optimization and improvement.
• Prepare solutions and equipment, ensuring smooth operation and efficiency.
• Stage components for autoclaving and washing, contributing to the production flow.
• Assist in the testing of production samples and leverage any experience with analytical instruments to enhance process accuracy.
• Actively participate in continuous improvement initiatives, helping to drive operational excellence.
• Contribute to safety audits and ensure that all activities align with industry standards and regulations.
• Ensure strict adherence to EHS, regulatory, and GMP requirements, maintaining a high level of compliance.
• Follow written procedures, quickly recognize malfunctions, and take prompt action to report and resolve issues.
• Evaluate documentation and data in line with company and regulatory guidelines, ensuring accuracy and compliance.
• Engage with internal and external inspectors, maintaining open communication and fostering transparency.
• Apply your knowledge of GMP to ensure the highest standards of production practices.
• Use basic statistical and mathematical skills to analyze data and make informed decisions.
• Effectively organize tasks, manage multiple priorities, and meet deadlines in a fast-paced environment.
• Leverage your understanding of basic chemistry, biology, and physical principles to support various plant operations.
• Have a solid grasp of analytical methods to ensure precision and quality in production.

Required Qualifications

• Diploma in Science or Engineering.
• NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences, or Bio-processing-related disciplines.
• Fresh graduates are highly encouraged to apply.
• Proficiency in reading and writing English.
• Strong commitment to cGMP and EHS compliance in clean-room plant operations (prior experience with cGMP is a plus).
• Knowledge of plant and unit operations (e.g., autoclaves, parts washers, process equipment) and strong problem-solving skills.
• Excellent self-motivated team player with a hands-on attitude and effective communication skills.
• Familiarity with systems like Emerson DeltaV, LIMS, and TrackWise.
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles.
• Willingness to work shifts, including 24/7 operations.
• Strong mechanical ability and expertise.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

As a Process Technician, you will support plant operations by assisting with troubleshooting, process optimization, and monitoring processing parameters. Your duties include preparing solutions, staging components for autoclaving, and aiding in production sample testing. You will ensure compliance with GMP, EHS standards, and regulatory requirements, follow procedures, evaluate documentation, and contribute to safety audits while working with internal and external inspectors.

Key Responsibilities

• Play a key role in the hands-on execution of plant operations while providing valuable support to Manufacturing Associates in troubleshooting and resolving issues.
• Monitor and analyze processing parameters to identify trends and uncover opportunities for process optimization and improvement.
• Prepare solutions and equipment, ensuring smooth operation and efficiency.
• Stage components for autoclaving and washing, contributing to the production flow.
• Assist in the testing of production samples and leverage any experience with analytical instruments to enhance process accuracy.
• Actively participate in continuous improvement initiatives, helping to drive operational excellence.
• Contribute to safety audits and ensure that all activities align with industry standards and regulations.
• Ensure strict adherence to EHS, regulatory, and GMP requirements, maintaining a high level of compliance.
• Follow written procedures, quickly recognize malfunctions, and take prompt action to report and resolve issues.
• Evaluate documentation and data in line with company and regulatory guidelines, ensuring accuracy and compliance.
• Engage with internal and external inspectors, maintaining open communication and fostering transparency.
• Apply your knowledge of GMP to ensure the highest standards of production practices.
• Use basic statistical and mathematical skills to analyze data and make informed decisions.
• Effectively organize tasks, manage multiple priorities, and meet deadlines in a fast-paced environment.
• Leverage your understanding of basic chemistry, biology, and physical principles to support various plant operations.
• Have a solid grasp of analytical methods to ensure precision and quality in production.

Required Qualifications

• Diploma in Science or Engineering.
• NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences, or Bio-processing-related disciplines.
• Fresh graduates are highly encouraged to apply.
• Proficiency in reading and writing English.
• Strong commitment to cGMP and EHS compliance in clean-room plant operations (prior experience with cGMP is a plus).
• Knowledge of plant and unit operations (e.g., autoclaves, parts washers, process equipment) and strong problem-solving skills.
• Excellent self-motivated team player with a hands-on attitude and effective communication skills.
• Familiarity with systems like Emerson DeltaV, LIMS, and TrackWise.
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles.
• Willingness to work shifts, including 24/7 operations.
• Strong mechanical ability and expertise.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Project Coordinator (PC) supports the Project Manager in delivering warehouse and logistics-related projects, ensuring alignment with scope, schedule, cost, quality, safety, and compliance requirements. The role focuses on coordination, monitoring, and governance of project activities across design, procurement, construction, commissioning, and turnover phases. The PC acts as a key interface between internal stakeholders, contractors, and vendors, ensuring smooth execution, issue resolution, and adherence to design intent and regulatory standards. The role covers warehouse infrastructure including freezers, weighing and dispensing systems, logistics flow (including automation such as AGVs), and related support systems.

Key Responsibilities

• Coordinate project workstreams across design, procurement, construction, commissioning, and qualification phases
• Act as primary interface between internal stakeholders, contractors, vendors, and functional teams
• Facilitate cross-functional coordination meetings and ensure alignment across engineering, operations, QA, EHS, and other functions
• Track project schedule, identify delays, manage critical path activities, and support recovery planning
• Monitor project budget, commitments, forecasts, and cost variances
• Support change management processes including scope, cost, schedule, and quality impacts
• Maintain and track project risks, issues, and mitigation actions
• Coordinate site activities including construction progress, logistics, and installation readiness
• Oversee contractor performance, ensuring quality, compliance, and adherence to specifications
• Ensure proper document control, including review, approval, and version management
• Prepare project status reports, dashboards, and presentations for governance forums
• Support stakeholder communication, expectation management, and decision-making processes
• Coordinate commissioning and qualification readiness, including system turnover and handover activities
• Ensure smooth transition from construction to commissioning and operations

Required Qualifications

• Degree in Engineering, Project Management, or related technical discipline
• Experience coordinating or supporting project work packages in engineering or construction environments
• Strong understanding of project scheduling, cost tracking, and progress monitoring
• Experience coordinating site activities, contractor works, and installation readiness
• Ability to interpret technical drawings, specifications, and project documentation
• Knowledge of engineering standards, GMP/GEP principles, and safety requirements
• Strong communication skills with ability to manage stakeholders and escalate issues effectively
• Good analytical and problem-solving skills with ability to manage multiple priorities
• Experience in warehouse, logistics, or infrastructure-related projects (preferred)
• Exposure to construction, facility build, or equipment installation environments (preferred)

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Validation Support role is responsible for supporting validation lifecycle activities across direct, indirect, and no-impact systems within a regulated pharmaceutical environment. The position ensures that equipment and systems remain in a qualified state through ongoing validation maintenance reviews, execution of qualification and requalification activities, and coordination with cross-functional stakeholders such as QA and QC. This role plays a key part in maintaining compliance with GMP requirements and ensuring validation documentation and processes are properly executed, reviewed, and approved.

Key Responsibilities

• Perform Validation Maintenance Reviews for direct, indirect, and no-impact systems
• Generate, review, and approve validation documentation (e.g. DQ, IQ, OQ, PQ) for new equipment qualification
• Plan and execute periodic requalification protocols for temperature chambers using data loggers/sensors
• Coordinate with cross-functional stakeholders (QA, QC, Engineering) to plan and align execution schedules
• Ensure validation activities are executed in compliance with GMP and internal quality standards
• Support audit readiness by maintaining accurate and complete validation documentation

Required Qualifications

• Diploma or Degree in Engineering, Life Sciences, Pharmacy, or related field
• Experience in validation or qualification activities within a GMP-regulated environment (pharma, biotech, medical devices)
• Familiarity with validation documentation (DQ, IQ, OQ, PQ)
• Understanding of temperature mapping, calibration, or equipment qualification processes
• Strong attention to detail and documentation accuracy
• Good communication skills for cross-functional coordination (QA/QC/Engineering)
• Ability to manage multiple tasks and meet project timelines

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking an experienced Computer System Validation (CSV) Specialist with strong expertise in isolator systems to support validation activities within a regulated life sciences environment. The successful candidate will play a key role in ensuring that automated systems associated with isolators are validated in compliance with regulatory expectations and industry best practices, using a paper-based validation approach.

Key Responsibilities

• Lead and execute CSV activities for isolator systems and associated software platforms
• Develop and review validation deliverables, including:
  - Validation Plans / Validation Master Plans (VMP)
  - User Requirements Specifications (URS)
  - Functional / Design Specifications (FS/DS)
  - Risk Assessments (GAMP 5 aligned)
  - IQ/OQ/PQ protocols and reports
  - Traceability Matrices
• Support system lifecycle validation from design through to decommissioning
• Apply risk-based validation approaches in line with industry standards
• Execute and manage paper-based validation documentation and approvals
• Collaborate with cross-functional teams (Engineering, Automation, QA, Vendors) to ensure alignment on validation scope and execution
• Review and assess vendor documentation for compliance and adequacy
• Support deviations, CAPA, and change control related to validated systems
• Ensure compliance with applicable regulatory standards (e.g., GxP, 21 CFR Part 11, Annex 11)

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline
• 3–8 years of experience in CSV within pharmaceutical / biotech environments
• Strong hands-on experience in isolator systems validation
• Familiarity with automation systems (e.g., PLC, SCADA, HMI) linked to isolators
• Experience working in a paper-based validation environment
• Good understanding of data integrity principles (ALCOA+)
• Experience with GAMP 5 and validation lifecycle methodologies
• Strong documentation and stakeholder communication skills

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking a Qualification Engineer lead commissioning, qualification, and validation (CQV) activities for HVAC systems, cleanrooms, and critical utilities within a GMP-regulated pharmaceutical environment.

The role will focus on end-to-end qualification lifecycle execution, ensuring compliance with EU GMP Annex 15, ASTM E2500, and industry best practices.

Key Responsibilities

• Commissioning & Qualification Execution
  - Support CQV lifecycle activities for HVAC, cleanrooms, and utilities systems (e.g., PW, WFI, Clean Steam, compressed air).
  - Execute IQ, OQ, and PQ protocols for facilities and utilities systems.
  - Participate in commissioning activities including system walkdowns and punch listing.
  - Perform functional testing and verification of system performance.
• Documentation & Protocol Development
  - Develop and/or execute qualification documents: URS (review), SIA (System Impact Assessment), Risk Assessments / Criticality Assessments
  - DQ, IQ, OQ, PQ protocols and reports
  - Ensure traceability through RTM (Requirements Traceability Matrix)
• HVAC & Cleanroom Qualification
  Perform or support:
  - Airflow visualization (smoke studies)
  - HEPA filter integrity testing (PAO/DOP)
  - Air velocity and air change rate verification
  - Temperature and humidity mapping
  - Room pressure cascade verification
• Utilities Qualification
  - Support qualification of:
  - Water systems (PW/WFI loops)
  - Clean steam systems
  - Compressed gases (CDA, nitrogen, oxygen)
  - Execute sampling and testing activities in collaboration with QA/QC teams
• Stakeholder Coordination
  Work closely with:
  - Engineering / Facilities teams
  - Vendors and system integrators
  - QA/Validation teams
  - Support FAT/SAT activities where required
• GMP Compliance & Quality
  - Ensure all activities comply with:
  - cGMP requirements
  - Data integrity (ALCOA+) principles
  - Support deviations, CAPA, and change control activities

Required Qualifications

• Education
  Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical or related discipline)
• Experience
  ~5 years of relevant CQV/Validation experience in pharmaceutical or biotech industry
• Hands-on experience in
  - HVAC / cleanroom qualification
  - Utilities systems qualification
  - Technical Skills
• Familiar with
  - EU GMP Annex 15
  - ASTM E2500
  - ISPE Baseline Guides (Volume 5 – Commissioning & Qualification)
• Strong understanding of
  - HVAC systems and cleanroom classifications (Grade A–D)
  - Utilities systems design and operation
• Soft Skills
  - Strong documentation and technical writing skills
  - Good stakeholder management and communication skills
  - Ability to work independently and in cross-functional teams

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The QA Validation professional provides quality oversight, review, and approval of validation and qualification activities to ensure compliance with GMP, regulatory expectations, and internal quality systems. This role ensures that validation deliverables are scientifically sound, risk-based, and inspection-ready, while supporting cross-functional project execution in a GMP-regulated environment.

Key Responsibilities

• Provide QA oversight for equipment, facility, utility, process, and cleaning validation and qualification activities
• Ensure validation approaches align with GMP, data integrity principles, and regulatory guidelines (e.g., FDA, EMA, PIC/S).
• Review validation strategies to ensure compliant, risk-based execution.
• Review and approve validation lifecycle documentation, including:
  - Validation Master Plan (VMP)
  - Risk assessments (e.g., FMEA, SRA)
  - URS, DQ, IQ, OQ, PQ
  - Cleaning validation protocols and reports
• Computer System Validation (CSV) documents, where applicable
• Ensure validation documentation is complete, traceable, and audit-ready
• Review and assess validation-related deviations, non-conformances, and investigations.
• Ensure appropriate root cause analysis and CAPA implementation.
• Support change control activities and assess validation impact.
• Support internal, customer, and regulatory inspections related to validation scope.
• Act as a QA validation subject matter representative during audits.
• Support timely closure of validation-related audit observations.
• Collaborate closely with Engineering, CQV, Manufacturing, QC, IT, and external vendors.
• Provide QA guidance during project phases, including new equipment introduction, upgrades, and revalidation.
• Support project timelines while maintaining compliance.
• Contribute to continuous improvement of validation and QA processes.
• Support updates to SOPs, templates, and validation standards.
• Promote a strong quality culture and right-first-time mindset.

Required Qualifications

• Diploma or Bachelors degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• 3–8+ years of experience in QA Validation, CQV, or Quality Assurance within GMP-regulated environments.
• Hands-on experience reviewing validation documentation for:
  - Process equipment
  - Utilities (e.g., WFI, clean steam, compressed gases)
  - Facilities and cleanrooms
  - Cleaning validation
• Experience with Computer System Validation (CSV) is an advantage.
• Strong understanding of GMP, data integrity, and validation lifecycle concepts.
• Familiarity with FDA, EMA, and PIC/S regulatory expectations.
• Strong documentation review and compliance mindset.
• Ability to challenge constructively while enabling project delivery.
• Good stakeholder engagement and communication skills.
• Detail-oriented, structured, and inspection-focused.
• Comfortable working in project-based and fast-paced environments.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.