Kodu
Senior Process Engineer
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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
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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
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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.
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