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).