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Senior CSV Engineer

Posted on Apr 24, 2020 by Experis AG

Bern, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Senior CSV Engineer

On behalf of one of our clients, a leading Medical Device company, we are looking for a Senior Qualification & Validation Engineer for a contract position until the end of the year located in Bern.

General information

  • Start date: ASAP
  • End date: 31.20
  • Extension: possible
  • Workload: 100%
  • Work location: Bern

Tasks & Responsibilities

  • In charge of commissioning and 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 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 subcontractors
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics

Must Haves

  • Bachelor/Master Degree in technical or natural sciences
  • A minimum of 3 years of working experience within pharma or a biotech company
  • Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
  • Know-how of quality assurance principles
  • Excellent communication skills
  • Analytical thinking and problem-solving ability
  • Business fluency in English (German language is a plus)
  • Furthermore, we are looking for a team player, self-starter, multitasker, and a good time manager

If you are a result-oriented Quality & Validation Engineer currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!

Reference: 882760463

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