Modis is looking for a leader for the commissioning and qualification activities on behalf of a client.
- Lead and direct the Commissioning and Qualification team Responsible for the compliance of all industrial assets, ensuring that the equipment meets regulatory requirements.
- Compliant implementation of new systems through the engineering project phase Maintaining compliance of existing systems by delivering appropriate re-qualification and periodic review
- Building compliant processes covering all aspects of the equipment lifecycle (VMP, VPP‘s, specifications, DQ, FAT/SAT, IQ, OQ, PQ & PPQ, requalification and periodic review)
- Design and implement execution strategies, ensure that adequate budget (opex and capex) is planned and spent in support of the C&Q team
- Master’s degree in Process-, Chemical–, Mechanical- or Bio Engineering
- 10+ year experiences in Commissioning, Qualification and Validation within the pharmaceutical or biotechnology sector Significant experience of leading C&Q teams in the pharmaceutical industry including biopharmaceutical, sterile fill finish and utility qualification activities, black and clean utilities, Computer Systems Validation,
- Act as a Subject Matter Expert in FAT (SAT) planning and execution
- English fluent, German higly preferd