Job Reference: JO-2005-65178_1622554008
Clean Utilities Engineer
- Act as Clean Utility Engineering Subject Matter Expert from the design phase to equipment handover.
- Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID's.
- SME in mechanical, electrical and pneumatic utility systems.
- Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programs.
- Support clean utility equipment installation, integration and coordinate vendor supervision as required.
- Review and approve process-related commissioning, qualification and validation protocols for completeness and accuracy.
- The leadership of clean utility and validation activities during the project life cycle.
Technical Skills and Experience:
- A relevant 3rd level qualification in an engineering, science or technical discipline (Degree Level or Master's preferable) with at least 5 years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering in Pharma, Biotech or Medical Device Industry.
- Previous experience in manufacturing biotechnological drugs, parenteral drugs, solutions preparation, fill-finish, Lyophilisation, sterilisation operations preferable. Experience in clean utilities is essential.
- Knowledge of policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations.
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