Role: Process Engineer
Location: Stevenage(onsite)
Duration: 12 months
Inside IR35 : Umbrella
Our client, a leader in the Life Sciences industry, is looking for a Process Engineer to join their Fibro Membrane Chromatography R&D team at their state-of-the-art facility in Stevenage. You’ll be part of a collaborative and innovative environment, working to develop life-changing solutions used in vaccines, medicines, and cutting-edge therapies.
As a key link between R&D and Manufacturing, you'll support the development, transfer, and implementation of processes and test methods – ensuring that high-quality, scalable solutions are ready for production
What you’ll do:
* Develop and implement new processes and equipment for manufacturing lines.
* Create and maintain documentation including SOPs, work instructions, and validation reports.
* Support Design for Manufacturability (DFM) initiatives using tools like pFMEA and Process Flow Charts.
* Lead or support qualification activities (FAT, SAT, IQ, OQ, PQ).
* Carry out method development, validation, and technical reports.
* Provide statistical analysis of process capability (e.g., CpK/Ppk).
* Collaborate closely with R&D, Production, and Quality teams.
Who you are:
* Min HNC (Higher National Certificate) in Science/Engineering discipline.
* Strong Process Engineering background and a detailed understanding of validation requirements for machine equipment, analytical methods and process.
* Experienced in PFMEA, DMAIC, 5S, Lean.
* Strong documentation skills (SOP, work instructions, IQ/OQ, URS, manufacturing plans, experimental reports, validation) with a keen eye for detail
* Work independently on work packages and collaborate well with many functions within R&D and Production.
It would be a plus if you also possess previous experience in:
* Experience in analytical method validation and process transfer.
* Familiarity with CAD (SolidWorks), Minitab, and statistical analysis tools.
Apply now to be part of a team where your work truly matters – to your colleagues, the business, and most importantly, to patients around the world.