Browse by job sector

User Rep

  1. North America, East Coast
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
36469
Apply to this job Save job
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!

#LI-AK1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

C&Q Engineer

Salary

Competitive

Location

Westport

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

West

Description

C&Q Engineer – Westport – Pharmaceuticals – Contract Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a C&Q Engineer to join their

Reference

36515

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Construction Project Manager

Salary

Competitive

Location

Ohio

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

Construction Project Manager - Ohio - 22 Months Contract This is a fantastic opportunity for a Construction Project Manager to join our major, global pharmaceutical client on their latest

Reference

36213

Expiry Date

01/01/0001

Annabel Nangle

Author

Annabel Nangle
Annabel Nangle

Author

Annabel Nangle
Read more
Read more
Construction Project Manager

Salary

Competitive

Location

Virginia

Salary

Competitive

Sector

CAPEX Projects

Job type

Permanent

Location

North America

East Coast

Description

Construction Project Manager - US, Virginia - Permanent Contract  This is your opportunity to work for a global data centre company that partners with the world’s largest technology firms to

Reference

37295

Expiry Date

01/01/0001

Alex McCrudden

Author

Alex McCrudden
Alex McCrudden

Author

Alex McCrudden
Read more
Read more

Insights

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

Your next step as a Validation Engineer
Read more

07/20/2021

pharmaceutical factory construction

Working in an organisation from Start Up Phase

Read more

06/28/2021

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV