Key Responsibilities:Perform DeltaV Batch configuration including recipes, phases, equipment modules (EM), and control modules (CM).Lead and execute DeltaV system validation activities, including authoring and executing IQ, OQ, and IOQ protocols.Mana..
Key Responsibilities:
Perform DeltaV Batch configuration including recipes, phases, equipment modules (EM), and control modules (CM).
Lead and execute DeltaV system validation activities, including authoring and executing IQ, OQ, and IOQ protocols.
Manage system administration and maintain configuration integrity across development, test, and production environments.
Troubleshoot, validate, and support integration of standalone systems with DeltaV DCS.
Lead automation commissioning and Site Acceptance Testing (SAT) for facility and equipment upgrades.
Manage and coordinate CQV (Commissioning, Qualification, and Validation) activities with cross-functional teams.
Generate and execute validation documentation for DeltaV and Rockwell BAS systems, in compliance with GAMP5, 21 CFR Part 11, and EU Annex 11.
Liaise with equipment vendors, internal stakeholders, and IT teams to implement upgrades and resolve system issues.
Provide routine operational support for automation and control systems including during preventive maintenance and shutdown periods.
Engage in incident resolution, root cause analysis, and implement corrective actions to maintain operational excellence.
Requirements:
Minimum 4 years of experience in automation engineering with a strong focus on DeltaV DCS.
Hands-on experience with validation and compliance for regulated environments (GMP, FDA, EU Annex 11).
Responsibilities:Provides expertise in performing Computerized Systems Validation.Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the fra..
Responsibilities:
Provides expertise in performing Computerized Systems Validation.
Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
Perform collaborative work with the Compliance Engineering team on other CQV activities.
Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
Investigate deviations and write deviation reports and findings.
Raise and follow-up change control records.
Requirements:
Degree in Engineering/Science or related studies.
Minimum of 4 years’ experience in relevant industry with at least 8 years in CSV, Quality Assurance, CQV, and Turnover Activities
High level of understanding in Regulatory compliance
Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS
