Sarah Donohue

Achievements / tasks

Expansion project;

• Installation and commissioning of new equipment in largest end-to-end CDMO in Europe, with a focus on Viral Filtration, Ultrafiltration, Product hold vessels, Water break tanks and process support equipment.
• Development, execution and approval of installation and operation test protocols and validation protocols
• Punchlist management, inter-departmental task coordination & daily project management reporting
• Automation design reviews and functionality verification
• Equipment vendor deliverables coordination and technical troubleshooting of equipment integration
• Key Strength: High standard of interdepartmental coordination with a sharp focus on maintaining project schedules

Daily operations

• Technical support of new manufacturing facility
• Sole on-call response covering all downstream equipment during technical runs, engineering runs and commercial batches
• Troubleshooting daily operations process issues with key focus on GMP compliance.
• Development of equipment operational procedures and safety documents, including work instructions and LOTO forms.
• Driving improvement projects for manufacturing associates including safety projects
• Supporting tech transfer activities for new direct impact processes including sole management of minor projects with budgetary considerations
• Key strength:Hands on attitude to process troubleshooting

• Turnkey process solutions, skid design and fabrication
• Joint management of Chromatography & Ultrafiltration skid fabrication project - Value of €4m
• Lead coordinator of Client FAT - preparation of FAT Protocols / Snag list management / Documentation collation. Participation in overseas Vessel FAT
• Preparation of Equipment, Valve & Instrumentation Schedules for client onsite IOQ operations, also Electrical I/O Lists, Datasheets, Documentation handover packs.
• Sole management of over 150 welding logs and associated material certs
• Coordination with craftsmen during skid fabrication and equipment testing
• Sanitary checks of P&ID’s and other related drawings, General Arrangement, Isometrics etc.
• Preparation of budget project estimates for global leading biopharmaceutical clients

• Material weights / Hold-up Volume / Pressure Drop calculations
• Documentation collation / Material Take Off’s / FAT prep