For our client, a global company in the pharmaceutical industry in Bern (Switzerland), we are looking for a motivated experienced candidate as
C&Q Engineer (f/m/d)
- Working experience within pharmaceuticals, biotechnologies or chemical industry
- Know-how of commissioning and qualification requirements according to (c)GMP regulation
- Know-how of quality assurance principles and experience working with cross-department stakeholders
- Experienced with GAMP5: Risk-based Approach to Compliant GxP Computerized Systems
- Know-how of ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
- Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partner
- Equipment knowledge
- QPCR, Wireless glove tester, HPLC and N2 generator, Tecan, Nexgen, Endoscan
- Waage und Titrator
- Biosafety cabinets
- Climate chambers, hot air sterilizer, fridge, freezer, incubator
Start date: ASAP
Actual End Date 31/12/2021 (temporary position)
Place of work: Bern
Please apply online. For further information about the position, please contact
your Kelly recruiter, Mrs Stefanie Bucheli +41 61 270 80 17.
We are looking forward to getting to know you!