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- Tasks: Validate and maintain manufacturing processes for medical devices, ensuring compliance with regulations.
- Company: Join Terumo Aortic, a leader in medical technology, during an exciting growth phase.
- Benefits: Enjoy excellent career progression and the chance to make a real difference.
- Why this job: Be part of a team that impacts healthcare through innovative manufacturing solutions.
- Qualifications: Degree in a scientific field with validation experience in a regulated environment.
- Other info: Collaborative culture focused on continuous improvement and professional development.
The predicted salary is between 36000 - 60000 £ per year.
Terumo Aortic are currently recruiting a Validation engineer to join our engineering team. This role will help support the business during a time of growth and investment on site. Working alongside the team you will be primarily accountable for the validation and validation maintenance of manufacturing processes, and test methods, manufacturing equipment and facilities. This is a fantastic opportunity to make a real difference and enjoy excellent career progression.
The main responsibilities of the role are;
- Primarily accountable for the validation and validation maintenance of manufacturing processes, and test methods, manufacturing equipment and facilities.
- Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives
- Perform validation of processes, equipment and facilities used in manufacture of medical devices to meet Regulatory requirements, this incorporates completion of validation protocol, installation qualification, operational qualification and performance qualification and supporting documentation
- Prepare and issue Validation Master Plans and schedules, summary reports and other required documentation for a validation exercise
- Organize and execute validation activities in order to provide an effective validation service
- Provide validation expertise to ensure that all operations are carried out in compliance with regulatory and company requirements
- Provide validation support and advice to other areas of the business as required
- Ensure projects relating to processes, facilities and equipment, are validated in line with regulatory and company requirements
- Provide specialist knowledge on process, facility, equipment issues within the site
- Promote effective working relationships and ensure they are maintained through the validation working party
- Support a continuous improvement culture within the business
- Provide guidance, and direction to staff consistent with appropriate standards
- Develop work plans, assign tasks, and supervise teams as appropriate
- Ensure staff have appropriate knowledge and training on department and site, processes and procedures
- Address site validation gaps via generation and completion of Validation Master Plans and schedules
- Maintain site validation status according to regulatory requirements
The successful candidate will possess;
- Degree qualified with validation experience from within a scientific regulated environment
- A good working knowledge of appropriate Standards and Regulations
- Experience in direct investigation/troubleshooting of validation problems
- Experience in Analytical Test Method Validation
- Experience in Equipment Qualification Good statistical knowledge (DOE, capability studies, Gauge R&R, sample size definition, etc)
- Experience in the areas of qualification, analytical methods, lab equipment qualification, computer system validation, and requalification
- Proficiency in Minitab and Microsoft packages
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Manufacturing Validation Engineer employer: Terumo Aortic
Contact Detail:
Terumo Aortic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manufacturing Validation Engineer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. 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 practising common questions and showcasing your validation expertise. Be ready to discuss your experience with regulatory requirements and how you've tackled validation challenges in the past.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for roles that excite you and fit your skills, like the Manufacturing Validation Engineer position at Terumo Aortic!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can leave a lasting impression and show your enthusiasm for the role. It’s a simple way to stand out from the crowd.
We think you need these skills to ace Manufacturing Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Manufacturing Validation Engineer role. Highlight your validation experience and any relevant qualifications that match the job description. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how you can contribute to our team. Keep it concise but impactful, showing us your personality and enthusiasm.
Showcase Relevant Experience: When detailing your experience, focus on specific projects or tasks that relate to validation processes and regulatory compliance. We love seeing concrete examples of how you've tackled challenges in a scientific regulated environment.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy and ensures your application goes straight to us. Plus, we can’t wait to see what you bring to the table!
How to prepare for a job interview at Terumo Aortic
✨Know Your Validation Stuff
Make sure you brush up on your knowledge of validation processes, especially in a regulated environment. Be ready to discuss your experience with installation qualification, operational qualification, and performance qualification. This will show that you understand the core responsibilities of the role.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled validation problems in the past. Think about specific situations where you had to troubleshoot issues or improve processes. This will demonstrate your analytical skills and ability to think on your feet, which is crucial for a Manufacturing Validation Engineer.
✨Familiarise Yourself with Regulatory Standards
Get to grips with the relevant standards and regulations that govern the manufacturing of medical devices. Being able to speak confidently about compliance will impress the interviewers and show that you're serious about maintaining high-quality standards.
✨Emphasise Teamwork and Communication
Since this role involves working closely with various teams, be prepared to discuss how you've built effective working relationships in the past. Highlight your ability to provide guidance and support to others, as well as your experience in promoting a continuous improvement culture.
