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C&Q Engineer

Engineering
Bern
English


Are you passionate about the pharmaceutical world? And highly open to join an international team in the development of solutions to help people to have a good life?
If your answers are yes, this great opportunity is for you ;)

Tasks and responsibilities:

The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for the Technical Services department in order to ensure that:

  • (re-) qualification of production/QC equipment including thermal mapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
  • Commissioning & Qualification Master plans are up to date and established for all ongoing projects.
  • Write/review Commissioning & Qualification plans and reports.
  • Execution of RQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities
  • Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelines
  • Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
  • Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners
  • Coordination and oversight of external suppliers


Qualifications:

  • Bachelor/Master’s degree in technical or natural sciences
  • Working experience within pharma/Medical Devices companies
  • K-how of Qualification requirements according to cGMP regulations
  • K-how of thermal mapping studies
  • K-how of quality assurance principles
  • Excellent communication skills
  • Analytical thinking and problem-solving ability
  • Business fluency in English. German language is a plus
  • Self time management


We thank you for your application :)