- Under the direction of Pharmaceutical Operations & Clinical Supply (Pharm Ops), responsible for providing engineering support to Pharmaceutical Sciences projects and initiatives, ensuring compliance and support primarily for the Laboratory areas but can be expanded to Pharm-Ops capital project support. This includes understanding GMP Quality systems as well as preparing and executing equipment / analytical system qualifications and validations. Primary location is RY.
- Selected Responsibilities: Support GMP Equipment / Analytical System lifecycle
- Qualification and validation documentation preparation and execution.
- Calibration and Maintenance support
- Equipment and Computer system periodic reviews
- Change Management and Investigation support
- Work and interact with cross-functional team members as required, in GSE, GES, GWES & MRL groups Capital Project management and administration in CCMS and CMMS computerized systems (SAP/ProCal) • CCMS – Computerized Calibration Management System (ProCal)
- CMMS – Computerized Maintenance Management System (SAP)
- Execute project administration activities (project creation, purchase orders, asset actions, etc.) Pharm Ops Engineering support
- Provide miscellaneous engineering support to Pharm Ops Engineering (POE) in terms of capital project, engineering, maintenance coordination, etc.
- Work and interact with cross-functional team members as required, in GSE, GES, GWES & MRL groups
GMP experience, quality systems, Laboratory, qualification, validation, SAP, Trackwise