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
Telefon: 058 255 31 04