Commissioning Engineer
Listed on 2026-06-14
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Engineering
Validation Engineer, Quality Engineering, Pharma Engineer, Biomedical Engineer
Are You a CQV Engineer With Experience on Major Projects?
If you are an experienced CQV Engineer thinking about your next contract move, we'd love to have a conversation now so we can move quickly when the time is right.
We are working with a key client on a large-scale biopharma capital programme in North Carolina and are keen to speak with strong upstream candidates ahead of requirements being confirmed.
About the RoleA CQV Engineer to be embedded within a large-scale biopharma project team, taking full ownership of commissioning, qualification and validation activities across upstream processing. You'll work with in a multi-disciplinary team on a Tier 1 client site, through Pragmatic Resource.
What You'll Be Doing Commissioning and Qualification- Execute C&Q activities across upstream systems from IQ through to PQ
- Work alongside the project team to ensure activities are planned, documented and delivered on schedule
- Author, review and execute validation protocols and reports in line with GMP requirements
- Support risk-based validation approaches in line with ASTM E2500 and ICH Q9/Q10
- Ensure all deliverables meet FDA, EMA and ICH requirements
- Manage deviations and maintain accurate documentation throughout
- Liaise with manufacturing, quality and engineering teams to support smooth system handover
- Support punch list management, scheduling and closeout across the wider C&Q team
- 3 to 7 years of CQV experience within pharmaceutical or biopharmaceutical manufacturing
- Hands‑on experience in upstream processing, covering bioreactors, media preparation, seed train and associated utilities
- Capital project or greenfield/brownfield facility experience a strong advantage
- Solid understanding of upstream GMP equipment, facilities and utilities
- Familiar with FDA, EMA and ICH regulatory requirements
- Competent in protocol authoring, deviation management and technical report writing
- Detail‑oriented and methodical with the ability to manage your own workload on a busy project site
- A team player comfortable working across disciplines
Location:
North Carolina, fully on-site
If your CQV background covers upstream biopharma and North Carolina is on your radar, get in touch now and let's have a conversation.
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