Find a job 
Featured Companies 
Featured Universities 
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 production.
- 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 43200 - 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…
#J-18808-Ljbffr
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 with professionals in the medical device industry, especially those who have experience in validation engineering. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
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 interviews will demonstrate your expertise and commitment to compliance.
✨Tip Number 3
Prepare to showcase your experience with validation methodologies like IQ/OQ/PQ. Think of specific examples from your past roles where you successfully implemented these processes, as this will highlight your practical knowledge and problem-solving skills.
✨Tip Number 4
Research the company’s products and recent developments in their manufacturing processes. This will not only help you understand their operations better but also allow you to ask insightful questions during the interview, showing your genuine interest in the role.
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 for any spelling 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 Validation Methodologies
Make sure you have a solid understanding of validation methodologies such as IQ, OQ, and PQ. Be prepared to discuss how you've applied these in your previous roles, as this will demonstrate your expertise and relevance to the position.
✨Familiarise Yourself with Regulatory Standards
Brush up on ISO 13485, FDA regulations, and EU MDR. Being able to articulate how you ensure compliance with these standards in your work will show that you are well-prepared for the responsibilities of the role.
✨Highlight Cross-Functional Collaboration
Prepare examples of how you've successfully collaborated with teams like Quality Assurance, R&D, and Manufacturing. This will illustrate your ability to work within a multidisciplinary team, which is crucial for this position.
✨Demonstrate Problem-Solving Skills
Be ready to discuss specific challenges you've faced in process validation and how you overcame them. This will showcase your problem-solving abilities and your capacity to maintain product quality and manufacturing consistency.
