Description
An exciting opportunity has arisen for experienced C&Q Engineer's to join this new state of the art multi-product biologics manufacturing facility.Working within the C&Q Team you will be required to perform the Commissioning, Qualification and Validation to complete the execution and start-up of this Cell Culture New build facility
After project completion this position will transition to continue validation activities and change control in support of the ongoing operations of the plant. Area of responsibility to be in one of the following work streams - either Biopharma equipment, cleaning validation, CSV, SIP Validation HVAC and Utilities
Key responsibilities will include (depending on experience and area of responsibility):
- CQV for equipment in one of the following areas associated with the manufacturing of biologics drug substance:
- Process support equipment including glasswashers, autoclaves and environmental chambers.
- Cleaning Validation.
- SIP Validation.
- HVAC and Utilities.
- CSV.
- Liaise with CQV start-up team in relation to punch list closure both pre-mechanical completion and during the CQV execution phase.
- Ensure commissioning readiness of all systems to support equipment start-up and PQ testing.
- Liaise with the Senior Validation Engineer in relation to generation and approval of: IOQ Summary Reports, Cycle Development Protocols and Reports, PQ Protocols and Reports.
- Write, review and update Standard Operating Procedures (SOP's) and Validation Plans (VPs) in accordance with site and corporate requirements.
- Support execution of all CQV deliverables.
- Ensure timely approval of all Commissioning and IOQ Final Reports for systems.
- Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9).
- Problem solving ability and excellent oral and written communications skills.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)