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- Tasks: Ensure quality and compliance of medical devices through validation processes and collaboration.
- Company: Join a leading Medical Device company with a focus on innovation and quality.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Why this job: Be at the forefront of medical technology and ensure safety for users.
- Qualifications: Bachelor's degree in engineering or life sciences and 5 years of validation experience.
- Other info: Dynamic team environment with opportunities for professional development.
The predicted salary is between 36000 - 60000 £ per year.
This is an exciting opportunity to join a Medical Device company with the manufacturing expertise to take new products through initial design and development through to high volume manufacture. Due to expansion, a new role has been created for a highly skilled and experienced Validation Engineer to join the Operations team in Suffolk. You will play a key role in ensuring the quality, safety, and compliance of the medical devices produced through the validation of manufacturing processes, equipment, and systems.
Key Responsibilities
- Develop, execute, and document validation protocols and reports for manufacturing processes, equipment, cleaning, and sterilisation processes.
- Ensure compliance with relevant regulatory standards such as ISO 13485, FDA and EU MDR.
- Collaborate with cross-functional teams including Quality Assurance, R&D, Regulatory and Manufacturing to support process improvements.
- Conduct risk assessments and validation lifecycle activities to ensure product quality and manufacturing consistency.
- Participate in audit preparations and support regulatory inspections related to validation activities.
- Maintain validation documentation in accordance with regulatory and company requirements.
Qualifications & Experience
- Bachelor's degree in engineering, life sciences or a related field (Chemical, Mechanical Engineering).
- Minimum of 5 years' experience in process validation within the medical device manufacturing industry.
- Strong understanding of validation methodologies (IQ/OQ/PQ) and validation lifecycle.
- Knowledge of regulatory standards (ISO 13485, FDA regulations, EU MDR).
- Experience with risk management tools and techniques.
- Data driven, comfortable using statistical software.
- Excellent problem-solving, communication, and organisational skills.
- Ability to work independently and as part of a multidisciplinary team.
Preferred Qualifications
- Previous experience in a Process Validation role in a CMDO or medical device manufacturer working at volume.
- Knowledge of the operation and constraints associated with high volume automation systems.
Lead Validation Engineer employer: Halian Technology Limited
Contact Detail:
Halian Technology Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Validation Engineer
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and FDA regulations. We recommend creating a cheat sheet with key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Don’t just wait for job postings! Be proactive and reach out directly to companies you admire, like us at StudySmarter. Express your interest in potential roles and share how your skills align with their needs.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Use this opportunity to reiterate your enthusiasm for the role and remind them why you’re the best fit.
We think you need these skills to ace Lead Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Lead Validation Engineer role. Highlight your experience in process validation and any relevant regulatory standards you've worked with. We want to see how your skills match 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 medical devices and how your background makes you a perfect fit for our team. We love hearing personal stories that connect to the role.
Showcase Your Problem-Solving Skills: In your application, don’t forget to mention specific examples of how you've tackled challenges in past roles. We value problem-solving abilities, especially in a fast-paced environment like ours!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Halian Technology Limited
✨Know Your Validation Methodologies
Make sure you brush up on your knowledge of validation methodologies like IQ, OQ, and PQ. Be ready to discuss how you've applied these in past roles, as this will show your expertise and understanding of the validation lifecycle.
✨Familiarise Yourself with Regulatory Standards
Since compliance is key in this role, take some time to review ISO 13485, FDA regulations, and EU MDR. Being able to speak confidently about these standards during your interview will demonstrate your readiness to ensure quality and safety in medical device manufacturing.
✨Prepare for Cross-Functional Collaboration Questions
Expect questions about working with teams like Quality Assurance, R&D, and Manufacturing. Think of specific examples where you collaborated on process improvements or tackled challenges together, as this will highlight your teamwork skills and adaptability.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss how you've approached risk assessments and validation lifecycle activities in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers, showcasing your analytical thinking and ability to maintain product quality.
