Qualification & Validation
Qualification & Validation Engineer
You run qualification campaigns at our Life Sciences clients, from protocol writing to closing out punch lists. You are the site’s counterpart on validated state.
Posted on
- Reference
- CV-2601
- Location
- Entzheim (France) · travel to client sites
- Contract
- Permanent
- Area
- Qualification & Validation
What you will do
Working with the practice lead, your role as Qualification & Validation Engineer is to:
- Write and execute IQ/OQ/PQ protocols
- Contribute to the Validation Master Plan (VMP) and risk assessments (FMEA)
- Investigate deviations and follow CAPA through to closure
- Maintain traceability from requirement to test to report
- Take part in maintaining the validated state and in periodic reviews
- Prepare inspection-ready documentation
Your profile
- Engineering degree or equivalent (MSc level) in process, biotech or industrial engineering
- First qualification experience in a GMP environment (pharmaceuticals, biotech or medical devices)
- Professional French and English
You are recognised for the following qualities:
- Documentary rigour — here, what is not written does not exist
- At ease on the shop floor as in meetings with quality assurance
- Analytical sense when facing deviations
- Enjoys teamwork and passing on knowledge
Your working environment
About C-Validation:
- An engineering firm founded and run by engineers who are still active in the field
- 4 areas of expertise: Commissioning, Qualification & Validation, Engineering Consultancy, Quality & Compliance
- Clients in Life Sciences, Supply Chain and Engineering
- Over 50 years of combined experience in the team
- A fast-growing company, hiring to keep developing
About the team:
The Qualification & Validation practice supports Life Sciences manufacturers in validating their processes and equipment, to ensure GMP compliance and product quality. It works around four themes:
- the Validation Master Plan (VMP) and risk assessments
- equipment qualification (IQ/OQ/PQ)
- cleaning, process and computerised system validation (CSV)
- maintaining the validated state and preparing for inspections
You are backed by the practice lead and work with our clients’ quality, production and project teams.
Working arrangements:
- Location: Entzheim (France) · travel to client sites
- Contract type: Permanent
- Expected start date: As soon as possible
- Work mode: On our clients’ sites, with travel
- All our positions are open to people with disabilities.
Don’t wait: join a fast-growing company where every file carries the name of the person who ran it.
Application
Qualification & Validation Engineer
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