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For Companies At a Glance
- Tasks: Lead validation of medical device manufacturing processes and ensure compliance with regulatory standards.
- Company: Join a dynamic Medical Device company known for innovation and high-quality manufacturing.
- Benefits: Enjoy competitive pay, career growth opportunities, and a collaborative work environment.
- Why this job: Make a real impact on product safety and quality while working with cutting-edge technology.
- Qualifications: Bachelor's degree in engineering or life sciences and 5+ years in process validation required.
- Other info: Ideal for those passionate about healthcare and eager to contribute to meaningful projects.
The predicted salary is between 48000 - 72000 £ per year.
Job Description
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& experiencedValidation Engineer to jointhe Operationsteam inSuffolk.You will play a key role in ensuring the quality, safety, and compliance ofthemedical devicesproducedthrough 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 andEU MDR.
Collaborate with cross-functional teams including Quality Assurance,R&D, Regulatoryand 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:
Bachelors degree in engineering,life sciencesor…
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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
Familiarise yourself with the specific regulatory standards mentioned in the job description, such as ISO 13485 and FDA regulations. Being able to discuss these standards confidently during an interview will demonstrate your expertise and commitment to compliance.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in validation roles. Attend industry conferences or webinars to make connections and learn about the latest trends and challenges in validation engineering.
✨Tip Number 3
Prepare to discuss specific examples of your past validation projects, particularly those that involved cross-functional collaboration. Highlighting your ability to work with teams from Quality Assurance, R&D, and Manufacturing will show that you can thrive in a multidisciplinary environment.
✨Tip Number 4
Brush up on your knowledge of risk management tools and statistical software. Being able to articulate how you've used these tools in previous roles will set you apart as a candidate who is data-driven and capable of ensuring product quality.
We think you need these skills to ace Lead Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in process validation, particularly within the medical device manufacturing industry. Emphasise your understanding of regulatory standards like ISO 13485 and FDA regulations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality and compliance in medical devices. Mention specific examples of how you've successfully developed and executed validation protocols in previous roles.
Highlight Key Skills: In your application, clearly outline your skills in risk management, problem-solving, and collaboration with cross-functional teams. These are crucial for the role and should be evident in your written materials.
Proofread Your Application: Before submitting, carefully proofread your application to eliminate any typos or grammatical errors. A polished application reflects your attention to detail, which is vital in the validation engineering field.
How to prepare for a job interview at Halian Technology Limited
✨Know Your Regulations
Familiarise yourself with ISO 13485, FDA regulations, and EU MDR. Be prepared to discuss how these standards impact validation processes and share examples of how you've ensured compliance in your previous roles.
✨Demonstrate Your Validation Expertise
Be ready to explain the validation methodologies you’ve used, such as IQ/OQ/PQ. Highlight specific projects where you developed and executed validation protocols, showcasing your hands-on experience in the medical device industry.
✨Showcase Your Collaboration Skills
Since this role involves working with cross-functional teams, prepare examples of how you've successfully collaborated with Quality Assurance, R&D, and Manufacturing. Emphasise your ability to communicate effectively and drive process improvements.
✨Prepare for Risk Assessment Questions
Expect questions about risk management tools and techniques. Be ready to discuss how you've conducted risk assessments in past projects and how you ensure product quality and manufacturing consistency through these activities.
