Senior Process Engineer

Senior Process Engineer

Production is running at tens of thousands of cartridges a month. The cartridge engineering team needs someone who can interrogate that data properly. Senior Process Engineer, near Bath, £60,000£65,000. Three days on site per week, with flexibility. If you own IQ/OQ/PQ end to end and know how to hold a contract manufacturer to account, read on.

Scope of the Role
The Senior Process Engineer owns process qualification, data analysis, and CMO oversight on a cartridge-based molecular diagnostic platform shipping at commercial scale. This is not a support seat. You lead the work.

Lead IQ, OQ, and PQ across two contract manufacturers and the on-site pilot line
Pull and interrogate production and QC data to surface patterns, not just headlines
Own change control and impact assessments with quality, regulatory, and engineering
Review and challenge CMO documentation, escalating where validation rigour falls short
Support cost-down and reliability projects including reagent redesign, polymer substitutions, and supplier changes

Key Skills and Experience Required
Extensive experience as a Senior Process Engineer, Process Engineer, Manufacturing Engineer, or Validation Engineer in a regulated medical device or IVD environment
Proven ownership of IQ, OQ, and PQ, including writing and executing protocols and pushing back on supplier documentation
Real CMO oversight experience, holding contract manufacturers accountable on validation, not just reviewing the paperwork they send
Strong data analysis capability using Minitab, Power Query, or equivalent, with working knowledge of SPC, DOE, and capability studies
Solid grounding in ISO 13485 or FDA QSR in day-to-day engineering practice, not just certification knowledge

Salary and Benefits
£60,000£65,000
Three days on site per week, with flexibility around data-heavy periods
Regular travel to European contract manufacturers, with the option to join Far East visits
Bonus, pension, and healthcare (details to be confirmed at offer stage)

This is an engineering team working on something that matters. The product is a molecular point-of-care diagnostic, the first of its kind to receive FDA clearance in its category, now shipping at volume after a $65m funding round. The Senior Process Engineer joining now steps into a properly resourced function with rich production data and a Director of Engineering who is technical enough to appreciate someone who argues from evidence. Engineering decisions still move the business here.

How to Apply
Want to find out more? Click apply and we'll be in touch.

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