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For Companies At a Glance
- Tasks: Ensure quality and compliance of medical devices through validation processes.
- Company: Join a leading Medical Device company with a focus on innovation.
- Benefits: Competitive salary, career growth, and a collaborative work environment.
- Why this job: Make a real impact in healthcare by ensuring product safety and quality.
- Qualifications: Bachelor's degree in engineering or life sciences and 5 years of validation experience.
- Other info: Dynamic team atmosphere 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 in Oxford 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 in Oxford
✨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 hunt for a Lead Validation Engineer role. You never know who might have the inside scoop on job openings or can put in a good word 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 and examples from your past experience that showcase your expertise in validation methodologies. This will help you stand out during those crucial conversations.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each company’s culture and mission. It shows you’re genuinely interested and not just sending out generic applications.
✨Tip Number 4
Follow up after interviews! A quick thank-you email reiterating your interest in the position and highlighting a key point from your conversation can leave a lasting impression. It shows you’re proactive and keen on the role, which is always a plus in the hiring process.
We think you need these skills to ace Lead Validation Engineer in Oxford
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 previous 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 for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
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 commitment to quality and safety in medical device manufacturing.
✨Prepare for Cross-Functional Collaboration
Think of examples where you've worked with teams from Quality Assurance, R&D, or Manufacturing. Highlighting your collaborative skills will show that you're a team player who can contribute to process improvements effectively.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss specific challenges you've faced in validation processes and how you overcame them. This will not only highlight your problem-solving abilities but also your analytical thinking, which is crucial in ensuring product quality.
