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User Rep

  1. North America, East Coast
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
36469
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User Rep - Pharmaceuticals - Contract - Ohio

This is a fantastic opportunity for a User Rep to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.

Responsibilities:
  • Act as the lead user representative for the HP-API suite design and build, working closely with design, engineering, and project management teams.
  • Collaborate with a cross-functional group including chemistry SMEs, CQV, Quality, and vendors to define and execute the technical scope.
  • Lead the development of User Requirements Specifications (URS) and participate in the review and approval of P&IDs and design deliverables.
  • Oversee the design and integration of small-scale manufacturing systems, from synthesis through conjugation and final drug substance filling.
  • Ensure OEB5 containment and GMP compliance is maintained throughout all phases of the project.
  • Represent user interests during Factory Acceptance Testing (FAT) and detailed design reviews, ensuring systems meet intended operational needs.
Skills and Experience:
  • Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, or a related scientific discipline.
  • Strong technical background in chemistry and prior hands-on experience in GMP lab or pilot plant environments.
  • Proven experience with high potency (OEB5) small molecule synthesis, ideally including ADC processes.
  • Demonstrated success creating user requirements, reviewing P&IDs, and collaborating with design and vendor teams.
  • Familiarity with GMP design requirements and ISO8 cleanroom operations.
If this role is of interest, please apply now!

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