Equipment Qualification & CSV Specialist

Responsibilities

• Participate in qualification activities related to the integration of an automated visual inspection line.
• Review and approve SAT protocols.
• Review and approve SAT reports.
• Draft IQ, OQ and PQ qualification protocols.
• Execute qualification tests in accordance with approved protocols.
• Write qualification reports and ensure documentary traceability.
• Identify, document and investigate deviations detected during qualification phases.
• Coordinate corrective actions and monitor deviation resolution.
• Ensure compliance of activities with GMP requirements and applicable quality standards.
• Participate in validation activities of embedded computerised systems.
• Ensure adherence to Data Integrity principles and 21 CFR Part 11 requirements.
• Collaborate closely with quality, engineering, automation teams and suppliers.

Candidate Profile

• Higher education in engineering, life sciences or a similar discipline.
• 5 to 10 years of experience in equipment qualification and validation in a pharmaceutical or medical device environment.
• Strong experience with complex automated lines and integrated industrial equipment.
• Proficiency in drafting and executing IQ/OQ/PQ protocols.
• Hands-on experience in performing qualification tests on site.
• Good knowledge of embedded computerised systems and their validation.
• Good knowledge of 21 CFR Part 11 regulations.
• Experience in managing, investigating and resolving deviations.
• Ability to work independently and proactively.
• Excellent writing skills in French and English.
• Analytical mindset, rigour and results orientation.

Terms and Benefits

• A temporary assignment to provide expertise.
• Participation in a strategic automation project in an international and innovative environment.
• High visibility, autonomy and collaboration with quality, validation and engineering experts.