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- 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 of relevant experience 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.
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 a related field(Chemical, Mechanical Engineering)
Minimum of 5years\’ experience inprocessvalidation 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
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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 relevant conferences or webinars to make connections and gain insights that could give you an edge in the application process.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with validation methodologies like IQ/OQ/PQ. Highlighting your hands-on experience will help you stand out as a candidate who can hit the ground running.
✨Tip Number 4
Showcase your problem-solving skills by preparing to discuss challenges you've faced in previous roles and how you overcame them. This will illustrate your ability to contribute positively to the team and handle the complexities of validation in a high-volume manufacturing environment.
We think you need these skills to ace Lead Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in process validation within the medical device manufacturing industry. Emphasise your understanding of regulatory standards like ISO 13485 and FDA regulations, as well as your experience with validation methodologies.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Explain how your skills and experiences align with the role, particularly your ability to collaborate with cross-functional teams and conduct risk assessments.
Showcase Relevant Projects: If you have worked on specific projects related to validation protocols or compliance with regulatory standards, mention these in your application. Use quantifiable results to demonstrate your impact and expertise in ensuring product quality.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial for a role focused on quality and compliance.
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 your experience aligns with these standards and how you can ensure compliance in the role.
✨Demonstrate Validation Methodologies
Be ready to explain your understanding of validation methodologies such as IQ/OQ/PQ. Share specific examples from your past work where you successfully implemented these processes.
✨Showcase Cross-Functional Collaboration
Highlight your experience working with cross-functional teams. Discuss how you have collaborated with Quality Assurance, R&D, and Manufacturing to drive process improvements and ensure product quality.
✨Prepare for Problem-Solving Scenarios
Expect to face problem-solving scenarios during the interview. Prepare examples that showcase your analytical skills and how you've tackled challenges in validation or manufacturing processes.
