Engineer Qualification & Validation/Ingénieur Qualification & Validation
Core
Ensuring compliance with major regulatory standards through qualification and validation of production and laboratory equipment across the site.
Role type
Qualification and Validation Engineer
Builds
Validated equipment and systems for pharmaceutical, biotech, and chemical manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, GAMP 5 rules, protocol writing, acceptance testing (FAT/SAT), IQ/OQ/PQ execution, non-conformity management, regulatory compliance
Preferred skills
Computerized systems validation, Quality Control department experience, Metrology
Technologies
GMP, GAMP 5, FAT, SAT, IQ, OQ, PQ, VMP
Responsibilities
Qualify production and laboratory equipment; Write and execute Installation, Operational, and Performance Qualification protocols; Draft Validation Plans and reports; Perform acceptance tests at supplier and customer sites; Manage associated non-conformities
Seniority
Entry to Mid-level, hands-on IC
