Equipment Qualification & CSV Specialist

• Take part in the integration of strategic automated equipment.
• Lead qualification activities and test execution.

About Our Client ##

Our client is a recognized international player in the medtech sector, committed to innovation and operational excellence.
Its stimulating environment offers the opportunity to participate in high value-added industrial projects in a demanding quality context.

Job Description ##

• Participate in qualification activities related to the integration of an automated visual inspection line.
• Review and approve SAT protocols.
• Review and approve SAT reports.
• Write 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 follow up on the resolution of deviations.
• Guarantee the compliance of activities with GMP requirements and applicable quality standards.
• Participate in validation activities for embedded computerized systems.
• Ensure compliance with Data Integrity principles and 21 CFR Part 11 requirements.
• Collaborate closely with quality, engineering, automation teams, and suppliers.

The Successful Applicant ##

• 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.
• Solid experience with complex automated lines and integrated industrial equipment.
• Proficiency in writing and executing IQ/OQ/PQ protocols.
• Practical experience in executing qualification tests in the field.
• Good knowledge of embedded computerized 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, rigor, and results orientation.

What's on Offer ##

• A temporary mission 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.

Quote job ref

JN-082026-7083817

Job Function

Engineering & Manufacturing

Specialisation

Quality

Industry

Healthcare / Pharmaceutical

Where

Lausanne Region

Contract Type

Interim

Job Reference

JN-082026-7083817