CQV EngineerÂ
CQV EngineerÂ
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
- Our client is currently building (started in 2024) a 125000 sq ft greenfield manufacturing facility outside of Pittsburgh PA.
- Expected to be operational by 2027 Q1.
- The electricity gets turned on in this facility in the end of Jan 2026.
- The facility will be state of the art and will be in partnership with U of Pitt.
- It will be focused on Gene Editing iPSC tech and cell vector and protein engineering capabilities.
- Our client is looking to add an Owners Rep CQV Engineer to help support the project.
- Currently all units have been delivered to the facility and they have started writing protocols Validation Master Plan and SOPs.
- Much of these are going to be mirror images from another facility of our clients at a different location. So part of the job will be compiling these docs.
- Once these items are completed they will set an overall Validation Strategy.
- This resource will serve as an Owners Rep CQV resource that will help coordinate review and support the efforts of the construction partner Turner.
- Coordinating with CQV team.
- Reviewing all protocols SOPs etc.
- Reviewing URS (Turner will draft).
- Make sure Turner has created all Turnover packages (VTOP CTOP ETOP).
- Support execution and review.
Responsibilities:
- This resource will serve as an Owners Rep CQV resource that will help coordinate review and support the efforts of the construction partner Turner.
- Coordinating with CQV team.
- Reviewing all protocols SOPs etc.
- Reviewing URS (Turner will draft).
- Make sure Turner has created all Turnover packages (VTOP CTOP ETOP).
- Support execution and review of all documents.
- Hands on Validation work on Autoclaves Bioreactors Biosafety cabinets and Clean Rooms.
Requirements:
- Prior experience as an Owners Rep CQV Engineer on a Greenfield build. Must have experience.
- Cell and Gene exp.
- Hands on validation experience supporting the execution of equipment specifically.
- Autoclaves Bioreactors Chillers Air Handling Units Biosafety cabinets and Clean Rooms.
- Coordinating with internal CQV team.
- Reviewing all protocols SOPs etc.
- Reviewing URS.
- Collecting and reviewing Turnover packages (VTOP CTOP ETOP).
- Support execution and review of all documents.
- KNEAT.
- VEEVA.
Employment Type
Full-time
