C&Q Engineer job in Bern, Switzerland

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Job type: Permanent

Discipline: Project Engineering

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Job Responsibilities:

In charge of commissioning and qualification (C&Q) activities for Technical Services department in order to ensure that:

Qualification/Validation Master plans are up to date and established for all ongoing projects in QC

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
Coordination and oversight of external suppliers
Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics

Skills and Requirements

Bachelor/Master Degree in technical or natural sciences
A minimum of 3 years of working experience within pharma company in C&Q equivalent position
Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
Know-how of ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
Excellent communication skills
Analytical thinking and problem-solving ability
Business fluency in English

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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