C&Q Engineer – 5189 ADA

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Commissioning & Qualification (C&Q) Engineer on a contract basis based in the Bern area.

 

The ideal candidate should have proven track record in Commissioning and Qualification, preferably with sound knowledge of QA principles in the pharmaceutical industry with excellent English and German language skills.

 

Main Responsibilities:

  • The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:
  • Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
  • Qualification/Validation Master plans are up to date and established for all ongoing projects
  • Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
  • Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
  • Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
  • Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
  • Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
  • Coordination and oversight of external suppliers

 Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • Bachelor/Master’s degree in technical or natural sciences
  • A minimum of 3 years of working experience within pharma company in C&Q/CQV equivalent position
  • Know-how of Qualification requirements according to cGMP regulations
  • Experience working with cross-department stakeholders
  • Know-how of Quality Assurance principles
  • Experience working in project teams and multiple projects in parallel
  • Experience working with 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
  • German language is a plus
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