Commissioning and qualification of systems is outsourced to the EPCM-CQ partner, who will be leading C&Q teams composed of C&Q Engineers. You will provide direction to the EPCM-CQ partner and you will monitor the C&Q activities to ensure project requirements are met and site procedures are followed.
A few of your tasks are:
- C&Q management, including planning, determining C&Q deliverables and setting out C&Q related strategies for the project.
- Act as an advocate of the C&Q Strategy and look for opportunities to improve that strategy.
- Act as subject matter expert for C&Q related topics.
- Monitor the C&Q activities carried out by third parties.
- Write Validation Project Plans and project close-out Validation Project Reports.
- Assess independently what equipment / systems should be commissioned and qualified according MSD practices and procedures and reviews this with QA.
- Review FAT, SAT, commissioning and qualification protocols and reports.
- You are responsible for the review of turn over packages established by suppliers and partners.
- MSc or experienced BSc degree in (Bio)chemical Engineering, Biochemistry, Applied Science.
- Pharmaceutical/biotech experience, sterile manufacturing C&Q experience a plus.
- Familiar with Last Planner methodology and pull planning.
- Excellent communication skills and a team player.
- Willing to work outside office hours
- Experience in the food or (bio)pharmaceutical industry, as a C&Q Manager or senior C&Q engineer.
- Good writing and planning skills.
- Fluent in English, Dutch is a plus.
Over de werkgever
XDES is specialist in recruitment van technisch personeel.
Wat wij bieden
A great job oppurtunity at an international healthcare company.
Uren per week:
023 55 78 529
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