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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 equipment manufacturing, during an exciting growth phase.
- Benefits: Enjoy career progression, competitive salary, and the chance to make a real impact.
- Why this job: Be part of a team that drives innovation in healthcare and supports continuous improvement.
- Qualifications: Degree in a scientific field with validation experience in a regulated environment.
- Other info: Dynamic work culture in Renfrew, Scotland, with opportunities for professional development.
The predicted salary is between 30000 - 50000 £ 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.
Responsibilities
- 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.
Qualifications
- 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.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
Location
Renfrew, Scotland, United Kingdom
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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, especially those already working at Terumo Aortic. A friendly chat can sometimes lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your validation knowledge. Be ready to discuss specific examples of how you've tackled validation challenges in the past. We want to see your problem-solving skills in action!
✨Tip Number 3
Show your passion for continuous improvement! Talk about any initiatives you've led or been part of that improved processes or compliance. This will demonstrate your commitment to quality and innovation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the team at Terumo Aortic.
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 relevant experience in validation processes, equipment qualification, and any regulatory knowledge you have. We want to see how your skills align with 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 this role and how you can contribute to our team. Be sure to mention any specific experiences that relate to the responsibilities outlined in the job description.
Showcase Your Skills: Don’t forget to showcase your technical skills, especially in areas like statistical analysis and analytical test method validation. We love seeing candidates who are proficient in tools like Minitab and Microsoft packages, so make sure to include those!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Terumo Aortic
✨Know Your Validation Basics
Make sure you brush up on your validation knowledge, especially around processes, equipment, and facilities. Be ready to discuss specific examples from your past experience where you successfully validated manufacturing processes or test methods.
✨Familiarise Yourself with Regulations
Since this role involves compliance with regulatory requirements, it’s crucial to understand the relevant standards and regulations. Prepare to talk about how you've navigated these in previous roles and how you can ensure compliance in this new position.
✨Showcase Your Problem-Solving Skills
Validation often involves troubleshooting issues. Think of a time when you faced a validation problem and how you resolved it. Be ready to explain your thought process and the steps you took to overcome the challenge.
✨Highlight Your Teamwork Experience
This role requires effective collaboration with various teams. Prepare examples that demonstrate your ability to work well with others, promote good relationships, and contribute to a continuous improvement culture within the business.
