At a Glance
- Tasks: Lead process qualification and data analysis for a cutting-edge diagnostic platform.
- Company: Innovative medical device company near Bath with a focus on quality and efficiency.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Other info: Join a dynamic team with a commitment to innovation and excellence.
- Why this job: Make a real impact in the medical field while leading exciting projects.
- Qualifications: Extensive experience in regulated environments and strong analytical skills.
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.
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.
Senior Process Engineer employer: Kodu
Kodu is an exceptional employer that fosters innovation and creativity in the field of robotic prosthetics. With a strong emphasis on employee growth, you will have the opportunity to take ownership of significant projects while enjoying a flexible hybrid working environment in Leeds. The collaborative work culture encourages direct access to technical leadership, making it a rewarding place for passionate engineers to thrive.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Process Engineer
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about letting people know you’re on the hunt for a Senior Process Engineer role. You never know who might have the inside scoop on an opportunity.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s products and processes. Since you’ll be interrogating data and leading process qualifications, show them you’re not just familiar with their work but genuinely excited about it. Bring your A-game!
✨Tip Number 3
Practice your storytelling skills! When discussing your experience, focus on specific examples where you’ve led projects or made significant improvements. This will help you stand out as someone who can take charge and drive results.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of resources to help you land that Senior Process Engineer position. Plus, it shows you’re serious about joining our team and makes it easier for us to find your application.
We think you need these skills to ace Senior Process Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Process Engineer role. Highlight your experience with IQ/OQ/PQ processes 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 this role. Mention specific projects where you've led process qualifications or worked with contract manufacturers, as this will grab our attention.
Showcase Your Data Skills:Since we’re all about interrogating data, make sure to showcase your analytical skills in your application. Provide examples of how you've pulled and interpreted production and QC data to drive improvements in past roles.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Kodu
✨Know Your Data Inside Out
As a Senior Process Engineer, you'll need to interrogate production and QC data effectively. Make sure you brush up on your data analysis skills and be prepared to discuss specific examples of how you've used data to drive improvements in past roles.
✨Master the IQ/OQ/PQ Process
Since this role involves owning the IQ, OQ, and PQ processes, it's crucial to demonstrate your understanding of these concepts. Prepare to explain your experience with these processes and how you've successfully implemented them in previous positions.
✨Showcase Your Leadership Skills
This isn't just a support role; you'll be leading the work. Be ready to share examples of how you've led projects or teams in the past, particularly in a regulated environment. Highlight your ability to hold contract manufacturers accountable and ensure quality standards are met.
✨Prepare for Change Control Discussions
You'll be responsible for change control and impact assessments, so think about how you've managed changes in previous roles. Be prepared to discuss specific challenges you've faced and how you navigated them while maintaining compliance and quality.
