Commissioning & Qualification (M/F)
Machine translation — original language: French.Show original
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:
- Define, apply, and monitor Commissioning/Qualification/Validation strategies for process equipment.
- Review/write criticality analyses and design qualification documents.
- Write FAT/SAT/IQ/OQ protocols and reports (automated systems) and execute field tests.
- Management of deviations and punch lists: root cause analysis, impact assessment, definition of CAPA.
- Supplier monitoring and compliance with the project schedule.
- Participation in or supervision (depending on level) of field tests, including dynamic SAT which may take place in 2x8 shifts.
- Supervision of subcontractors and, for the experienced profile, the OSA team.
- Reporting to CQV supervision and project management (supervisory profile).
Profile sought:
- Mandatory experience in process equipment qualification:
- Mastery of P&ID, nomenclatures, and good notions of automated systems: SCADA, API, Grafcet, recipe management, historization.
- Organization, autonomy, and the ability to manage multiple activities simultaneously.
- Excellent communication skills to interact with suppliers, subcontractors, and internal teams.
- Knowledge of SIEMENS/PCS7 appreciated.
- Professional English (oral/written) mandatory.