Commissioning & Qualification Engineer

Beschreibung

Working for a Medical Device client in Switzerland

Job title: Commissioning & Qualification Engineer

Professional background

* 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

* Fluent English & Conversational German required

Michael Bailey International is acting as an Employment Business in relation to this vacancy.