Qualification & Validation Specialist – CSV Systems & Equipment
Aubonne, Switzerland
About the Role
Merck is looking for a
Qualification & Validation Specialist
to support computerized systems (CSV) and equipment validation at our Aubonne site. You'll ensure compliance with cGMP standards, data integrity, and smooth project execution while driving continuous improvement.
What You'll Do
* Lead and execute qualification & validation activities (FAT/SAT/IQ/OQ/PQ)
* Draft and maintain validation documentation (plans, protocols, reports, traceability matrices)
* Coordinate external providers and manage deviations
* Support IT/OT validation (e.g. Trackwise, GLIMS, cybersecurity, global data historian)
* Drive process improvements and efficiency initiatives
What We're Looking For
* Engineering degree with
5–10 years' pharma validation/CSV experience
* Strong knowledge of 21 CFR Part 11, GAMP 5, and cGMP practices
* Experience with equipment validation (filling lines, packaging, utilities, biotech systems)
* Familiarity with risk analysis tools (FMECA, AMDEC) and Lean/Six Sigma
* Fluent in
French & English
, excellent communication and teamwork skills
Details
* Start Date:
November 2025
* Location:
Aubonne, Switzerland
* Languages:
French & English
Interested? Apply now or send your CV to
f.-