C&Q Engineer (M/F)

MEENT is a leading company in the life sciences field, offering solid expertise in engineering consulting and clinical research. Our commitment to innovation and quality allows us to provide tailored solutions in response to the complex challenges of our clients in the Healthcare sector.

The position:

• Drafting of qualification documents: DQ, FAT, SAT, risk analyses, traceability matrices, IQ/OQ/PQ protocols and reports.
• Execution of DQ/FAT/SAT/IQ/OQ/PQ qualification tests.
• Monitoring of FAT-SAT tests.
• Integration of C&Q deliverables into the main project schedule.
• Collaborates effectively with all stakeholders, communicates progress, issues, potential risks, and proposes solutions.
• Management of any deviations.

Profile sought:

• Profile with 3-5 years of experience in the pharmaceutical sector (manufacturing and facilities), mastery of qualification processes (IQ, OQ, PQ).
• In-depth knowledge of requirements in terms of equipment qualification / validation (granulator, dryer, weighing, HVAC'), networks (purified water, compressed air, - ), automated systems, and facilities.
• Knowledge of 21 CFR part 11, EU cGMP annex 11, risk analysis (AMDEC or FMEA), component-function impact analysis according to ISPE.
• Good writing skills: maintaining documentation systems, creating clear and concise technical documentation, ensuring data integrity and deviation management.
• Reading and understanding of technical documentation: P&ID plans, electrical diagrams, user manuals, architecture diagrams.
• In-depth knowledge and mastery of Good Manufacturing Practices.
• Good interpersonal skills, transversal management, project team management.
• Ability to be proactive, innovative, and to propose solutions.
• Language: Professional English (written and oral)