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CHE Senior Engineer/ Eng. Team Leader (m/w/d)(Ref.Nr. PS2871)

We are looking for a person who can:

Job Purpose/ Role:

  • Ensure efficient, timely, GMP and safety compliant maintenance of engineering equipment, through expert knowledge, documentation and education on engineering procedures and sequences.
  • Ensure design, execution and hand-over of mid-size investment projects within cost, time schedule, quality and functionality.
  • Repair and Maintenance cost targets ~ GMP/HSE compliance ~ Project targets fulfilment Adherence to Site KPIs

More details: Reg Eng RV Site CGT is a part of a local SD Engineering and support the Stein Cell and Gene Therapy (CGT) Production and QC Equipment in corrective and preventive Maintenance.

  • As a Plant Engineer you will support in following topics:
  • Leading root cause investigation for product deviations, recalls.
  • Troubleshooting management
  • Spare parts management
  • Support for inspection
  • Provide frontline support for technicians
  • Deviation / Action / CAPA and Quality event management
  • Technical change request management (ACC)
  • Work order management (SAP – PM)
  • SPOC for all analytical, production, supply chain and MS&T equipment’s
  • Support maintenance planning and scheduling management (SAP – PM)
  • Review in the system for standard operating instructions (SOPs / FRMs and WPs)
  • COMOS Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)
  • Develop test specification / plan for commissioning & qualification in projects
  • Perform GMP risk assessments (incl. Sensors SRA)
  • Create DQ, IQ and OQ protocols
  • Execute DQ, IQ and OQ
  • Create DQ, IQ and OQ reports
  • Provide technical trouble shooting during PQ and validation

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA:

You Should Have:


  • German and English language
Start Date: 15.08.2022
Duration: 8 1/2 month (till 30.04.2023)
Location: Stein
Salary: to be discussed

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