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- 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 manufacturing.
- Benefits: Enjoy competitive pay, career growth opportunities, and a collaborative work environment.
- Why this job: Make a real impact on product quality and safety 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 48000 - 72000 £ 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& 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 a related field(Chemical, Mechanical Engineering)
Minimum of 5years\’ experience inprocessvalidation 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
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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 industry conferences or webinars to make connections and gain insights that could give you an edge in your application.
✨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 for scenario-based questions. Think of challenges you've faced in previous roles and how you overcame them, particularly in relation to process validation and risk management.
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 validation methodologies and regulatory standards like ISO 13485 and FDA regulations.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Explain how your skills and experiences align with the role, particularly your experience with risk assessments and collaboration with cross-functional teams.
Showcase Relevant Skills: In your application, clearly demonstrate your problem-solving abilities and familiarity with statistical software. Mention any specific tools or techniques you have used in previous roles that relate to 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 for a role focused on quality and compliance.
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, executed, and documented validation protocols, showcasing your attention to detail and thoroughness.
✨Showcase Your Collaboration Skills
Since this role involves working with cross-functional teams, prepare examples of how you've successfully collaborated with Quality Assurance, R&D, and Manufacturing. Emphasise your communication skills and ability to work within a multidisciplinary team.
✨Prepare for Problem-Solving Questions
Expect questions that assess your problem-solving abilities. Think of scenarios where you identified risks or issues during the validation lifecycle and how you addressed them. Use data-driven examples to illustrate your approach.
