CQV Engineer - CIP
Role and responsibilities:
- Aligning with JE on System boundaries and Lead and review exercise.
- Liaise with JE in relation to construction readiness and a schedule for all CIP/SIP systems, perform and lead all field walk downs for all systems.
- Assist CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the CIP/SIP scope.
- Ensure Commissioning readiness of all CIP/SIP Systems to support Equipment Start-up and IOQ Testing.
- Assist CQV CIP/SIP with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems.
- Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all CIP/SIP Systems are managed appropriately for the entire Project Lifecycle.
- Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols
- Execution of all CIP/SIP CQV deliverables; FAT/SAT/IOQ
- On completion of C&Q activities for CIP/SIP systems, be responsible for the writing of the Cleaning Validation Plans and Procedures, supporting the Cleaning Validation for all Equipment.
- CIP/SIP Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
- Experience with complex projects and working in or around operating facilities.
- Ability to keep work pace and meet deadlines. Good organizing and planning skills.
- Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
- Proven success working well in a team environment with flexibility to react to changing business needs.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project
CQV Lead required to join a global biotech company located in the north of Ireland. The CQV lead will specifically be responsible for clean utilities implementation onto a greenfield biotech site. R
Ireland is a hive of activity at present for the Life Sciences Industry. We are currently working with a global Biopharmaceutical company who are heavily investing in their Dublin facility. The sit
Opportunity to work for one of the largest Bioloigic companies in Europe. With more than 600 products manufactured and over 200 in the pipeline this company are expanding and therefore require a Lead
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