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For Companies At a Glance
- 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, competitive salary, and a supportive team environment.
- Why this job: Make a real difference in healthcare while developing your skills in a dynamic setting.
- 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, 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, 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.
Manufacturing Validation Engineer in Inchinnan employer: Terumo Aortic
Contact Detail:
Terumo Aortic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manufacturing Validation Engineer in Inchinnan
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Validation Engineer role.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and regulatory standards. We recommend practising common interview questions related to validation processes and equipment. Show them you’re the expert they need!
✨Tip Number 3
Don’t forget to showcase your problem-solving skills! Be ready to discuss past experiences where you tackled validation challenges. We want to see how you think on your feet and handle real-world issues.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. Let’s get you that Validation Engineer position!
We think you need these skills to ace Manufacturing Validation Engineer in Inchinnan
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. Be sure to mention any specific experiences that relate to validation processes and regulatory requirements.
Showcase Your Technical Skills: Don’t forget to highlight your technical skills, especially in areas like Analytical Test Method Validation and Equipment Qualification. We love seeing candidates who are proficient in tools like Minitab and have a good grasp of statistical knowledge!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Terumo Aortic
✨Know Your Validation Basics
Make sure you brush up on your knowledge of validation processes, especially in a regulated environment. Be ready to discuss installation qualification, operational qualification, and performance qualification, as these are key aspects of the role.
✨Showcase Your Problem-Solving Skills
Prepare examples from your past experience where you've successfully tackled validation issues. Companies love candidates who can demonstrate their troubleshooting abilities, so think of specific instances where you made a difference.
✨Familiarise Yourself with Regulatory Standards
Since this role involves compliance with regulatory requirements, it’s crucial to be well-versed in the relevant standards. Brush up on your knowledge of regulations that govern medical device manufacturing to show you’re serious about the role.
✨Highlight Your Teamwork Experience
Validation often requires collaboration with various teams. Be prepared to discuss how you've worked effectively with others in the past, and how you can promote effective working relationships within the validation working party.