CQV Engineer

We are looking for an experienced CQV consultant to support qualification and validation activities in a pharmaceutical environment. This is a temporary position for a duration of 6 months. The role involves managing equipment qualification projects and, ideally, computerized system validation (CSV). Experience in chemical production is highly desirable.

Main Responsibilities

• Commissioning & Qualification:
  • Drafting and reviewing IQ/OQ/PQ protocols.
  • Performing qualification tests on production equipment.
  • Managing deviations and implementing CAPAs.
  • Preparing and following up on qualification reports.
• Validation:
  • Computerized System Validation (CSV) according to GAMP 5.
  • Drafting URS, FS, DS, and test protocols.
  • Ensuring compliance with regulatory requirements (FDA, EMA).
• Documentation & Compliance:
  • Guaranteeing traceability and document compliance.
  • Adhering to GMP standards and internal guidelines.
• Coordination:
  • Collaborating with production, quality, and engineering teams.
  • Participating in project meetings and providing regular reporting.

Profile

• Experience: Minimum 5 years in CQV roles with full mastery of associated activities (IQ/OQ/PQ qualification, protocol drafting, deviation management, CSV validation).
• Technical Skills:
  • Qualification of pharmaceutical production equipment.
  • Knowledge of computerized systems and CSV validation (a plus).
  • Ideally, experience in chemical production.
• Languages: Fluent in French and English (spoken and written).