For our client, an international company based in Bern, we are seeking a highly skilled Commissioning and Qualification Engineer for a 6-month contract.
As a Commissioning and Qualification Engineer, you will play a crucial role in ensuring the successful commissioning and qualification of facilities, systems, and equipment in manufacturing production and QC in compliance with applicable regulations and industry standards.
General Information:
- Start date: ASAP
- End date: 31.12.2024
- Extension: possible
- Workplace: Bern
- Workload: 100%
Key Responsibilities:
The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:
- (re-) qualification of production/QC equipment is performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Write/review Commissioning & Qualification plans and reports.
- Execution of RQ, IQ, OQ including protocol deviations, investigation, and corrective action activities
- Plan and track execution of commissioning & qualification activities/documentation versus project(s) timelines.
- Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification documentation)
- Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners
- Coordination and oversight of external suppliers
...