Site Eng. Head 100%

Site Eng. Head 100%


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

Special Requirement for this role:

  • language German / English
  • SAP-PM/ ACC/ 1QEM Investigator

Marilu Mercedes
Marilu Mercedes
Telefon: 058 255 31 04

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