CQV Downstream Engineer
- North America, East Coast
- Contract
- CAPEX Projects
Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV Downstream 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.
Essential Duties and Responsibilities for this role include, but are not limited to:
- Senior CQV Engineer for Equipment in the Downstream Area for the DSM Building, initially responsible for review of all Design deliverables from Jacobs including Drawings, Datasheets, specifications, and Engineering Lists.
- Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
- Generate Downstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
- Point CQV person for Vendor review for all Downstream Vendor Packages. CQV SME for all Downstream Systems.
- Liaise with Jacobs in relation to construction readiness and a schedule for all Downstream systems, perform and lead all field walk downs for all systems.
- Lead 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 punch list closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Downstream Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all Downstream Systems to support Equipment Start-up and IOQ Testing.
- Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
- Lead CQV Downstream Systems with EIDA, ensure full trace ability at all times for all systems.
- Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Downstream Systems are managed appropriately for the entire Project Life cycle.
- 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
- Lead execution of all Downstream systems and CQV deliverables; FAT/SAT/IOQ
- Run Weekly CQV Downstream Meeting and ensure updates are provided to Weekly CQV Meeting.
- Generate and ensure timely approval of all SAT and IOQ Final Reports.
Requirements:
- Extensive CQV Downstream Equipment experience on Large Scale Projects
- SME on all Downstream Systems experience
- Working knowledge of ASTM E2500 / Leveraging Verification process
- Experience with liaising with other departments and building PMs/leads
- Extensive Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
- Extensive experience in Leading Equipment CQV Team
- 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.
- Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
If you are interested, please apply now for immediate consideration and further information.
#LI-MC1
I have always received a highly professional & personable service from the team at QCS Staffing. 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 QCS Staffing for seven years now and have always received a professional service. QCS Staffing'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 QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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
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