commissioning & qualification engineer (thermomapping specialist) in Bern

Thu Barany, Zurich IT Professionals
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job details

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reference number
thu barany, zurich it professionals
058 201 56 60

job description

We are currently supporting a leading pharmaceutical company in Bern, in their search for an experienced Commissioning & Qualification Engineer (thermomapping specialist).Responsibilities:
  • You 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:
- (re-) qualification of production/QC equipment including Thermomapping studies 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 and final reports
  • Execution of IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities
  • 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 commissioning activities in collaboration with internal and external partners
  • Coordination and oversight of external suppliers
  • Bachelor/Master’s degree in technical or natural sciences
  • Working experience within pharma/Medical Devices companies
  • Know-how of Qualification requirements according to cGMP regulations
  • Know-how of thermomapping studies
  • Know-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
If this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today. Please note that we are only considering applications from Swiss and EU-27/EFTA nationals or Swiss work permit holders for our open positions in Switzerland.