Total 4 Project Coordinator job vacancies in Quality Assurance / Control category in CH - Visp

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

For our Quality Assurance team in Bioconjugates we are currently looking for a dedicated person who would like to work as a Senior QA Specialist, Project Manager (f/m/d) in a fast growing and innovative environment. The person will support clinical phase manufacturing and will interact with internal and external stakeholders to represent Quality.

Key responsibilities:

• As a member of the quality assurance team (Bioconjugates), you will be responsible to ensure production of API`s is in accordance with Good Manufacturing Practice (GMP)

• Support the contract manufacturing and advise members of development, production and analytical departments on all aspects of GMP

• Responsible for checking manufacturing documentation for conformity, processing of change controls and reviewing and approving of deviations and OOS-results

• In addition, you will be the quality contact for our clients, and will present during their GMP audits

Key requirements:

• A degree in Life Science (microbiology, biotechnology, chemistry)

• Relevant experience in the biopharmaceutical industry, ideally in GMP area

• Strong communication skills, experience in working with stakeholders from different departments

• Experience with TrackWise, SAP, LIMS and DMS is a plus

• Fluency in English (writing and speaking) is required for stakeholder communication, German skills on B1 level are required to interact with colleagues on a daily bases

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Associate Director, Compliance and Project Support, Automation Biologics

Location – Visp, Switzerland

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The site in Visp, Switzerland is growing and for our Biologics organization, we are seeking a senior Manager Automation who can manage our Compliance and Project Support team with significant experience in DeltaV and MES and a passion for Biotechnology to join our Lonza talent community. Become part of this exciting opportunity and apply now for the position as senior Manager Automation Ops Readiness.

Key Responsibilities:

• Managing a team of Senior automation experts and specialists with full responsibility for all aspects of human resource management such as development, coaching, hiring, pay decisions and discipline issues;
• Managing a local Center of Excellence for Operations Automation (Delta V, Syncade) of bioprocesses;
• Working with the team in Capital investment projects and strengthening the respective automation teams with expert knowledge on process automation;
• Working with the global Center of Excellence to standardize automation approaches in biopharma manufacturing;
• Providing high-level troubleshooting support with the team;
• Collaborating with the Operations to provide resource plans for automation set-up;
• Driving the ambition level for automation in the design of the facilities by incorporating innovation, operational improvements, and other aspects influencing the manufacturing costs;
• Contributing automation expertise to design development teams;
• Managing the automation teams during the initial engineering phases and providing leadership to cross-functional teams of experts;
• Supporting LONZA culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside specific area of responsibility.

Key requirements:

• Recognized expert in the area of Bioprocess Automation (OT, Delta V, MES Syncade)
• Deep understanding of bioprocesses, GMP and biopharma production
• Strong leadership skills
• Ability to communicate internally and externally at higher levels; strong business understanding, strong team orientation
• Structured and proactive working attitude
• Open-minded for new ideas

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

#LI-SG

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

In this role you will be part of Quality Assurance activities for Capex project as part of the Global Quality Engineering team. Projects will be part of Lonza’s Biologics growth portfolio  in Lonza’s IBEX BioPark in Visp. We are looking for an experienced quality assurance colleagues with drive to ensure the projects are completed on-time with a compliance mindset to add to our high performing team.

Key responsibilities:

• Owning all quality related responsibilities for the CQV Lifecycle Program for new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs

• Support the development, review and release of qualification documents according to the Validation Master plan for process plants with specific expertise on documentation for clean utilities

• Support and approve quality risk analyses

• Release of the qualified process equipment and ensure equipment is assessed with appropriate change management

• Ensure all deviations are appropriately investigated and recorded

• Responsible to drive CAPA and effectiveness check items to completion and timely closing

• Actively supports the Quality culture as a role model

Key requirements:

• Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field

• Significant experience in the GMP regulated pharmaceutical industry; preferable in a QA role

• Strong background in cGMP regulations and expertise in the qualification of Clean Utilities

• Experienced in the interaction with health authorities (Swissmedic, FDA etc.)

• Excellent verbal, written and interpersonal communication skills in English

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Currently we are looking for a Project Quality Lead to join our multinational Quality organization in the Bioconjugates Business Unit at the Visp site. This role acts as key Quality counterpart for CAPEX projects and is responsible for leading quality activities by working closely with various quality and operational functions to ensure GMP-compliant manufacturing and documentation.

Key responsibilities:

• End-to-end lead for all Quality activities and a key role in project leadership level

• Responsible to deliver the project activities by implementing capabilities that support the success of the assigned investment projects

• In depth awareness of entire process, identifying business and operational factors that influence the project - as well as provide quality input as required

• Collaborating with local and global Engineering and Global Quality Engineering stakeholders for improvement projects

• Leading the CAPEX Project Quality team, managing a team of experienced quality professionals. Distributing tasks and maintain oversight of main activities

• Managing project scope, timelines, compliance, Regulatory (e.g Swiss Medic)

• Ensuring the primary responsibilities of the team are executed in line with corporate requirements, industry best practices and current regulatory requirements (cGMPs)

Key requirements:

• Degree in Biology, Chemistry, Biotechnology, Life Science or other related field or experience in the field of pharmaceutical industry

• Substantial work experience in a role in Quality Assurance, Production or Engineering, within pharmaceutical industries and cGMP controlled environment

• Strong experience in QA quality and validation

• Excellent knowledge of computer systems (e.g. TW, SAP, etc), quality tools such as risk based approaches

• Fluent in English, German is strongly preferred

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.