CQV Project Manager
Exciting opportunity to work for a world-renowned biotech manufacturer and to be a part of an impressive expansion project.
The site is starting commissioning now and requires a Project Manager to take control of the full CQV masterplan on behalf of the Global group. You will be joining a full-scale biotech manufacturing plant, responsible for end-to-end capabilities.
- Managing the commissioning/qualification disciplines.
- Prepares and keeps up-to-date the pre-commissioning and commissioning execution plans (including the schedule and the mobilization of personnel and equipment).
- Develop Commissioning/Qualification Schedule, harmonization with overall project schedule in line with Global Group.
- Supervises the preparation of the operation and performance tests and of the operating manuals with the process team + manufacturing associates.
- Develop, plan and execute Commissioning/Qualification concept/strategy (CQP, Structure of Documents, Commissioning/IQ/OQ/PQ); Standardization of all commissioning/qualification documents.
- Responsible for the availability of all necessary and requested commissioning and qualification documentation and execution according to the overall project schedule.
- Assists the Global Project Manager in contacts with User representatives for the handover of the plant.
- Responsible for all C&Q results and strive for final evaluation.
- Ensures the preparation of final summaries reports or certificates.
- CQV Project Management experience within a large-scale mammalian cell culture facility.
- Experience leading multi-disciplined Engineering groups (CQV, CSV, Manufacturing).
The candidate must have the rights to work in the location stated in the job advert.
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