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