DPFG Engineer
- North America, East Coast
- Contract
- Life Sciences
Our client, a global pharmaceutical manufacturing organization are looking for a talented DPFG 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:
- CQV Engineer responsible for supporting all DPFG CQV scope in the DPFG Buildings.
- Responsible for supporting and at times, managing the teams executing the Fill Finish, Packaging and Finished Goods CQV scope in that building.
- Review of Fill Finish, Packaging and Finished Goods design deliverables from Jacobs including Drawings, Datasheets, specifications and Engineering Lists.
- Generation of all CQV Packaging and Finished Goods Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
- Generation of Packaging and Finished Goods Bridging documents, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
- Vendor review for all Packaging and Finished Goods Vendor Packages.
- Work alongside CQV SMEs for all Drug Product, Packaging and Finished Goods Systems.
- Liaise with Jacobs in relation to construction readiness and a schedule for all Drug Product, Packaging and Finished Goods systems, perform and lead all field walk downs for all systems.
- 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 Packaging and Finished Goods and related support systems.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Packaging and Finished Goods Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all Packaging and Finished Goods Systems and related Support Equipment Start-up and IOQ Testing.
- Requires extensive Bio or pharma related experience
- Degree related to Engineering or similar
- Ability to be full time on site in Raleigh
#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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