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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 Portsmouth 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 Portsmouth
✨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 demonstrate your expertise in validation methodologies. This will help you stand out during those crucial conversations.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, be ready to discuss specific challenges you've faced in process validation and how you tackled them. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make a lasting impression.
✨Tip Number 4
Don't forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications and updates all in one place.
We think you need these skills to ace Lead Validation Engineer in Portsmouth
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, especially in the context of medical device manufacturing.
✨Familiarise Yourself with Regulatory Standards
Get comfortable with ISO 13485, FDA regulations, and EU MDR. You might be asked specific questions about compliance, so having examples of how you've ensured adherence to these standards will really impress.
✨Showcase Your Collaboration Skills
Since this role involves working with cross-functional teams, prepare examples that highlight your teamwork. Think of times when you collaborated with Quality Assurance, R&D, or Manufacturing to improve processes.
✨Prepare for Risk Assessment Questions
Be ready to discuss your experience with risk management tools and techniques. Have a couple of scenarios in mind where you conducted risk assessments and how they impacted product quality and manufacturing consistency.
