C&Q Engineer

Highly Competitive
  1. Permanent
  2. Project Engineering
  3. Switzerland
Bern, Switzerland
Posting date: 03 Jun 2021

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.