Vacature: CSV Specialist
Werkgever:Lonza
Plaats:Geleen
CSV Specialist
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.
Due to a need to further build and develop the Qualification and Validation Team, Lonza are excited to announce the creation of several new roles to be based at our site in Geleen, including a CSV Specialist. This specialized role will focus on Computerized System Validation activities and is a highly important Subject Matter Expert within the wider team. This represents an exciting chance to take on a niche position within a dynamic and diverse group at Lonza, offering excellent potential for growth and development.
Key responsibilities:
- The CSV Engineer will be involved in all Computerized System Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others. The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
- Generates and executes (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix. Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP requirements among others.
- Develops CSV Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
- Supports regulatory and client audits as CSV subject matter expert.
- Work to identify efficiencies in the CSV program approach. Work to apply lessons learned, and stay informed of industry regulatory changes as it applies to CSV / 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5.
- Perform assigned Quality Systems activities including Document Management system, Change Control, Non Conformities, and CAPA’s.
- Writing and/or revising procedures applicable to CSV activities.
- Support the Engineering group to prepare the validation, requalification and maintenance program.
Key requirements:
- Bachelor degree or equivalent in a relevant subject area.
- Demonstrable experience within CSV in a GMP environment (or similar), and an excellent understanding of good documentation practices, data integrity and ALCOA++.
- Knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11 and GAMP 5.
- 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.
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