CQV Engineer

Overview

On Site
Full Time

Skills

Manufacturing
Art
Collaboration
Partnership
Editing
Writing
Adobe AIR
URS
Turnover
Veeva

Job Details

Job Description:
  • Our client is currently building (started in 2024) a 125,000 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 Owner's 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 Owner's 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 Owner's 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 Owner's Rep CQV Engineer on a Greenfield build. Must have experience.
  • Cell and Gene exp.
  • Hands on validation experience supporting the execution of equipment, specifically.
  • utoclaves, 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.
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