For one of our prestigious clients in medical devices, we are looking for a qualification engineer available ASAP.

Main missions:

1. Manage qualification activities throughout the lifecycle (URS, impact analysis, FAT/SAT, IQ/OQ/PQ, commissioning and requalification).
2. Write, execute and approve qualification and validation documentation: protocols, reports, risk analyses, change controls, deviations and qualification plans.
3. Ensure the maintenance of the qualified status of equipment by coordinating maintenance, calibration, periodic requalification and compliance monitoring activities.
4. Participate in process validation / Computer System Validation (CSV) activities on a targeted scope, notably for computerised laboratory systems and equipment.
5. Support installation, transfer or equipment upgrade projects, ensuring compliance with regulatory, quality and operational requirements.

Profile sought:

• Engineering degree or Master’s (pharmaceutical, chemistry, biotechnology, industrial engineering or equivalent)
• Minimum 5 years’ experience in equipment qualification, preferably in a laboratory
• Proven experience in IQ / OQ / PQ qualification
• Good knowledge of GMP, deviation management, change control and risk analysis
• Experience in CSV (Computerised System Validation) is appreciated
• Field-oriented profile, autonomous, with good writing skills and multi-stakeholder coordination abilities.