Computerised System Validation (CSV) Engineer

What you will do

Working with the practice lead, your role as Computerised System Validation (CSV) Engineer is to:

• Build a system’s validation strategy in line with GAMP 5
• Write URS, risk assessments and traceability matrices
• Write and execute IQ/OQ/PQ protocols for computerised systems
• Check compliance with 21 CFR Part 11 and Annex 11
• Implement Data Integrity principles (ALCOA+)
• Support change controls and periodic system reviews

Your profile

• Engineering degree or equivalent (MSc level) in industrial IT, automation or process engineering
• First experience in CSV or qualification in a GMP environment
• Professional French and English

You are recognised for the following qualities:

• Rigour and attention to detail
• At ease talking to IT as well as to quality
• Clear, concise writing
• Curious about automated systems

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 CSV, Automation & ASRS practice validates our clients’ computerised and automated systems, from design to operation, ensuring data integrity and regulatory compliance. It works around four themes:

• computerised system validation (CSV) in line with GAMP 5
• data integrity (ALCOA+) and 21 CFR Part 11
• qualification of automation and ASRS systems
• inspection preparation (ANSM, EMA, FDA)

You are backed by the practice lead and work with our clients’ quality, IT and automation teams.

Working arrangements:

• Location: Entzheim (France) · client sites
• Contract type: Permanent
• Expected start date: As soon as possible
• Work mode: Hybrid: Entzheim office and client sites
• 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.