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- Tasks: Assist in software validation and manage vendor documentation for medical devices.
- Company: Established pharmaceutical client with a focus on innovation.
- Benefits: Competitive contract rate, hands-on experience, and potential for long-term work.
- Other info: Opportunity to work on exciting projects with excellent career growth potential.
- Why this job: Join a dynamic team and make a real impact in the medical device industry.
- Qualifications: Experience in validation, automation, and strong troubleshooting skills required.
The predicted salary is between 40000 - 50000 £ per year.
A well-established pharmaceutical client is looking for a CSV Engineer to assist with their ongoing project. This will be a 6 month initial project, with the total workload expected to run for 9-12 months. The role is heavily focused on software validation (Delta V), and needs a fully site based professional.
Responsibilities will include:
- Generation of execution of Risk Assessments, URS, DQ, RTM and IOQ protocol and IOQ Reports
- P&ID Walkdowns
- Review of Vendor FAT / SAT documentation and vendor TTOPs
- Execution of systems with PCS interface
- Vendor Management during SAT execution, witnessing and signing SAT documentation on behalf of client
- Raising of deviations through to their resolution and closure of deviation
Technical Requirements:
- Strong hands-on field execution experience from start-up / energization to shakedown and testing
- Delta V
- Strong automation background for troubleshooting
- Ideally experience with programming / coding
- Strong trouble shooting experience during field execution
- Familiar with LOTO, Safe Plan of Action and PSSR
- GMP regulations, GAMP5, 21CFR Part 11, EU Annex 11, Data Integrity requirements
If you have a strong background in Validation and Automation, then please get in touch to discuss further.
Regulatory Engineer- Medical Devices employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Engineer- Medical Devices
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical devices and pharmaceutical sectors. Attend industry events or webinars, and don’t be shy about connecting on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews! Research the company and their projects, especially around software validation and Delta V. We recommend practising common interview questions and even some technical scenarios related to your field. Confidence is key!
✨Tip Number 3
Showcase your skills! Create a portfolio or a detailed list of your past projects, especially those involving risk assessments and vendor management. We want to see how you’ve tackled challenges in the past, so make it easy for potential employers to see your value.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for talented individuals like you to join our team. Don’t miss out on the chance to land that dream job!
We think you need these skills to ace Regulatory Engineer- Medical Devices
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Engineer role. Highlight your experience with software validation, especially with Delta V, and any relevant automation skills. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills align with our needs. Don’t forget to mention your hands-on experience and familiarity with GMP regulations – we love that stuff!
Showcase Relevant Projects: If you've worked on similar projects before, make sure to showcase them in your application. We’re interested in your field execution experience and any troubleshooting you've done during start-up or testing phases. Let us know what you've achieved!
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. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at X4 Life Sciences
✨Know Your Stuff
Make sure you brush up on your knowledge of software validation, especially Delta V. Familiarise yourself with the technical requirements listed in the job description, like GMP regulations and GAMP5. Being able to discuss these topics confidently will show that you're serious about the role.
✨Prepare for Practical Questions
Expect questions that dive into your hands-on experience with field execution and troubleshooting. Think of specific examples from your past work where you successfully managed risk assessments or vendor management during SAT execution. This will help you demonstrate your practical skills effectively.
✨Show Your Problem-Solving Skills
Be ready to discuss how you've tackled challenges in previous roles, particularly in automation and coding. Prepare a couple of scenarios where you resolved deviations or improved processes. This will highlight your ability to think critically and act decisively under pressure.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the project. Inquire about their current challenges with software validation or how they approach vendor management. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.