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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…
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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
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 an interview will demonstrate your expertise and commitment to compliance.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in validation roles. Attend relevant conferences or webinars to make connections and gain insights that could give you an edge in the application process.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with validation methodologies like IQ/OQ/PQ. Highlighting your hands-on experience will help you stand out as a candidate who can hit the ground running.
✨Tip Number 4
Showcase your problem-solving skills by preparing to discuss challenges you've faced in previous roles and how you overcame them. This will illustrate your ability to contribute positively to the team and handle the complexities of validation in a high-volume manufacturing environment.
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 within the medical device manufacturing industry. Emphasise your understanding of regulatory standards like ISO 13485 and FDA regulations, as well as your experience with validation methodologies.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific examples from your past work that demonstrate your skills in developing and executing validation protocols, and how you have collaborated with cross-functional teams.
Highlight Relevant Skills: Clearly outline your problem-solving, communication, and organisational skills in your application. Provide examples of how you've used these skills in previous roles, particularly in relation to risk assessments and validation lifecycle activities.
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 crucial in the validation engineering field.
How to prepare for a job interview at Halian Technology Limited
✨Know Your Regulations
Familiarise yourself with ISO 13485, FDA regulations, and EU MDR. Be prepared to discuss how these standards impact validation processes and share examples of how you've ensured compliance in your previous roles.
✨Demonstrate Your Validation Expertise
Be ready to explain the validation methodologies you’ve used, such as IQ/OQ/PQ. Highlight specific projects where you developed and executed validation protocols, showcasing your hands-on experience in the medical device industry.
✨Showcase Your Problem-Solving Skills
Prepare to discuss challenges you've faced in validation processes and how you overcame them. Use data-driven examples to illustrate your analytical skills and your ability to improve manufacturing consistency.
✨Collaborate Effectively
Since the role involves working with cross-functional teams, be ready to talk about your experience collaborating with Quality Assurance, R&D, and Manufacturing. Share instances where your teamwork led to successful process improvements or audit preparations.
