For our client, a leading international pharmaceutical company based in Bern (Switzerland), we are looking for a motivated personality in the function of
Commissioning & Qualification Engineer (m/f), 100% Bern
- Support of continuous improvement on process, and on Qualification and Validation projects.
- Generate and execute CQV protocols using Good Documentation Practices (GDPs).
- Investigate and resolve protocol exceptions or discrepancies.
- Develop technical reports and CQV summary reports.
- Collaboration in the creation of user requirements (URS).
- Create / check DQ, IQ, OQ and PQ documents.
- Participation in GMP relevance and risk analyses.
- Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation (CAPA etc).
- BSc/MSc degree in Engineering or Chemistry or any related field.
- 5 years working experience within pharmaceuticals, biotechnologies or chemical industry
- Know-how of commissioning and qualification requirements according to (c)GMP regulations
- Know-how of quality assurance principles and experience working with cross-department stakeholders
- 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 partners
Place of work: Bern
Start date: May 2021
End date: December 2021
Please apply online. For further information about the position, please contact: Mrs Insa Voss (+41 61 270 80 07).
We are looking forward to getting to know you!