Senior Process Engineer
hace 3 días
Bath
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 RoleThe 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 linePull and interrogate production and QC data to surface patterns, not just headlinesOwn change control and impact assessments with quality, regulatory, and engineeringReview and challenge CMO documentation, escalating where validation rigour falls shortSupport cost-down and reliability projects including reagent redesign, polymer substitutions, and supplier changesKey Skills and Experience RequiredExtensive experience as a Senior Process Engineer, Process Engineer, Manufacturing Engineer, or Validation Engineer in a regulated medical device or IVD environmentProven ownership of IQ, OQ, and PQ, including writing and executing protocols and pushing back on supplier documentationReal CMO oversight experience, holding contract manufacturers accountable on validation, not just reviewing the paperwork they sendStrong data analysis capability using Minitab, Power Query, or equivalent, with working knowledge of SPC, DOE, and capability studiesSolid grounding in ISO 13485 or FDA QSR in day-to-day engineering practice, not just certification knowledgeSalary and Benefits£60,000£65,000Three days on site per week, with flexibility around data-heavy periodsRegular travel to European contract manufacturers, with the option to join Far East visitsBonus, 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 ApplyWant to find out more? Click apply and we'll be in touch.TPBN1_UKTJ