At a Glance
- Tasks: Lead process qualification and data analysis for innovative diagnostic products.
- Company: Dynamic engineering team focused on impactful medical technology.
- Benefits: Competitive salary, bonus, pension, healthcare, and flexible working arrangements.
- Other info: Opportunity for travel and career growth in a supportive engineering culture.
- Why this job: Join a pioneering team making a difference in healthcare with cutting-edge diagnostics.
- Qualifications: Extensive experience in regulated environments and strong data analysis skills required.
The predicted salary is between 60000 - 65000 £ per year.
Production is running at tens of thousands of cartridges a month. The cartridge engineering team needs someone who can interrogate that data properly.
The Senior Process Engineer owns process qualification, data analysis, and CMO oversight on a cartridge-based molecular diagnostic platform shipping at commercial scale.
- 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.
- Support cost-down and reliability projects, including reagent redesign, polymer substitutions, and supplier changes.
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.
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.
Locations
Senior Process Engineer/Process Engineer in Bath, Somerset employer: Kodu
Join a forward-thinking engineering team near Bath, where your expertise as a Senior Process Engineer will directly contribute to the development of groundbreaking molecular diagnostic products. With a strong emphasis on data analysis and process qualification, you'll enjoy a flexible work environment that promotes professional growth and collaboration, alongside competitive benefits including a bonus, pension, and healthcare. This is an opportunity to be part of a mission-driven company that values evidence-based decision-making and innovation in the medical device sector.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Process Engineer/Process Engineer in Bath, Somerset
✨Tip Number 1
Network like a pro! Reach out to your connections in the engineering field, especially those who have experience with contract manufacturers. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Show off your data skills! When you get the chance to meet potential employers, be ready to discuss how you've used data analysis in past roles. Bring examples of how you've interrogated production data to drive improvements.
✨Tip Number 3
Prepare for the interview by brushing up on IQ/OQ/PQ processes. Be ready to explain how you've owned these processes in previous jobs and how you can hold contract manufacturers accountable. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! We’ve got some fantastic opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications!
We think you need these skills to ace Senior Process Engineer/Process Engineer in Bath, Somerset
Some tips for your application 🫡
Tailor Your CV:Make sure your CV speaks directly to the job description. Highlight your experience with IQ/OQ/PQ and any relevant data analysis skills. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Senior Process Engineer role. Share specific examples of how you've held contract manufacturers accountable and tackled data analysis challenges.
Show Off Your Data Skills:Since we’re all about data, make sure to showcase your proficiency with tools like Minitab or Power Query. Mention any projects where you’ve used these skills to drive improvements or surface insights from production data.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come in directly!
How to prepare for a job interview at Kodu
✨Know Your Data Inside Out
Make sure you’re well-versed in data analysis techniques, especially using tools like Minitab or Power Query. Be prepared to discuss how you've pulled and interrogated production and QC data in the past, and be ready to share specific examples of patterns you've identified.
✨Showcase Your CMO Oversight Experience
Highlight your real-world experience in holding contract manufacturers accountable. Prepare to discuss instances where you’ve pushed back on supplier documentation and how you ensured compliance with IQ, OQ, and PQ protocols.
✨Understand Regulatory Standards
Brush up on ISO 13485 and FDA QSR regulations, but don’t just recite them. Be ready to explain how you’ve applied these standards in your day-to-day engineering practice, showcasing your practical knowledge rather than just theoretical understanding.
✨Be Ready for Technical Discussions
Expect to engage in technical conversations with the Director of Engineering. Prepare to argue your points with evidence, demonstrating your ability to make data-driven decisions that impact engineering outcomes. Think about how your previous projects align with the company’s goals.
