Senior CQV Expert

Senior CQV Expert 

Today, Lonza is a global leader in life sciences operating across five 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. 

Due to a need to further build and develop the Engineering CQV Team, Lonza are excited to announce the creation of a Senior CQV Expert role to be based at our site in Geleen. This represents an amazing opportunity to join a diverse and dynamic team in a fast-paced environment with fantastic potential for growth and development, in a role with excellent variety, where there’s always a new challenge to overcome. 

What you’ll do: 

• Provide guidance and expertise during validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.  

• Ensure the implementation and building of new standards and processes. 

• Technical review and support of validation documents including URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ). 

• Support during execution of IQ/OQ and PQ for equipment, systems and utilities. 

• Review and approve reports of completed validation activities. 

• Work to identify efficiencies in the validation program approach. Work to apply lessons learned, and stay informed of industry regulatory changes as it applies to equipment / facility validation. 

• Perform assigned Quality Systems activities including Document Management system, Change Control, Non Conformities, and CAPA’s. 

• Writing and/or revising procedures applicable to the Engineering activities. 

• Support the Engineering group to prepare the validation, requalification and maintenance program. 

What we’re looking for: 

• Bachelor degree or equivalent in a relevant subject area. 

• Flexibility and adaptability, able to perform in an ever-changing environment. 

• Excellent understanding and expertise of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Qualification, Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment as well as Computerized Systems Validation. 

• Excellent knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11 and GAMP 5. 

• Excellent understanding of good documentation practices and data integrity.  

• Strong planning skills and self-motivated, able to work autonomously. 

• Business-level fluency in English; other languages are nice to have but not required. 

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. 

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.