Quality Engineer

April 4, 2024

we are looking for...

Quality Engineer

Contracting

Ref: BH-1994

Quality Engineer

Job details

Contracting

Ref: BH-1994

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Quality Engineer

We are seeking a Quality Engineer for a CAPEX project, aimed at supporting the Project Team in ensuring operational readiness for a fill-finish aseptic line project.

Primary Responsibilities:

  • Overseeing quality and regulatory aspects of the assigned CAPEX project
  • Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility throughout the project lifecycle, from design engineering to initial C&Q and handover phases
  • Reviewing and approving C&Q documents for GMP systems, as well as associated changes and deviations
  • Supporting audits and regulatory inspections
  • Providing leadership and guidance to project team members regarding C&Q strategy and issues
  • Ensuring decisions are supported by both global and local Quality, as well as Regulatory
  • Promptly escalating issues and taking leadership in their resolution

Key Requirements:

  • Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field
  • Extensive experience in the GMP regulated pharmaceutical industry, preferably in a Quality Unit role
  • Previous experience in QA for C&Q of GMP systems related to aseptic fill-finish processes and facilities (e.g., filling equipment, lyophilization, clean utilities, and clean room facilities)
  • Proficiency in English; German language advantageous

Please apply directly online with your CV.

**Please only apply if you are eligible to work in Switzerland and the EU**

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