Senior CSV Engineer

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!

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