CIP Validation Documentation Engineer
- East Coast
- Contract
- Commissioning, Qualification and Validation
Our client, a global Pharmaceutical manufacturing organization are looking for a talented CIP Validation Documentation Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Responsibilities:
- CQV Support Engineer for all CIP Equipment in the DSM Buildings, initially responsible for review of all Design deliverables from the CM including Drawings, Datasheets, specifications and Engineering Lists.
- Support generation of all CQV CIP Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
- Point CQV person for Vendor review for all CIP Vendor Packages.
- CQV SME for all CIP Systems. Produce CIP Bridging to include all CCP, CQAs and worst case information of circuits.
- Support all circuit reviews for all CIP routes and circuits, working out “worst case” scenarios for testing and cleaning requirements.
- Liaise with construction manager in relation to construction readiness and a schedule for all CIP systems, perform and Support all field walkdowns for all systems.
- Support CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope.
- Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems.
- Liaise with CQV PM and Support Scheduler in relation to schedule creation and management for all CIP Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all CIP Systems to support Equipment Start-up and IOQ Testing.
- Support PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
- Support CQV CIP Systems 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 Systems are managed appropriately for the entire Project Lifecycle.
- Liaise with CQV Document Generation Support in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols
- Support execution of all CIP systems and CQV deliverables; FAT/SAT/IOQ
- Run Weekly CQV CIP Meeting and ensure updates are provided to Weekly CQV Meeting.
- Generate and ensure timely approval of all SAT and IOQ Final Reports.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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