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