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- Tasks: Join us as a Manufacturing Process Engineer, optimising processes in clean room environments.
- Company: Be part of a leading UK start-up revolutionising scientific instrumentation and analytics.
- Benefits: Enjoy 25 days annual leave, private health insurance, and generous parental leave policies.
- Why this job: Make an impact in medical device manufacturing while collaborating with innovative teams.
- Qualifications: Bachelor's degree in Engineering and 5-7 years in clean room process engineering required.
- Other info: Access to LinkedIn Learning and ongoing training for personal and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
An opportunity to join one of the UK’s most successful start-ups in scientific instrumentation and analytics. This company has developed and commercialised their Adeno-Associated Virus (AAV) and Lentiviral vectors (LVV) analytical equipment. Seeking a skilled and detail-oriented Manufacturing Process Engineer to support the consumables manufacturing operations. This role requires a strong focus on clean room environments, ensuring compliance with quality standards and driving continuous improvements.
About the role:
- Develop, implement, and optimize manufacturing processes for consumables, with a focus on operations in clean room environments.
- Ensure all manufacturing processes meet regulatory and quality standards, including GMP requirements.
- Monitor and control environmental conditions within clean room spaces to maintain compliance.
- Lead troubleshooting efforts for production issues, identifying root causes, and implementing corrective actions for all our consumables portfolio.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Supply Chain, to facilitate product development and transfer to manufacturing.
- Conduct risk assessments and develop validation protocols (IQ/OQ/PQ) for clean room equipment and processes.
- Develop and maintain detailed process documentation, including clean room SOPs, SOP work instructions, and training materials for goods in QC as well as operators training.
- Train production staff on all manufacturing processes including clean room protocols, gowning procedures, and process best practices.
- Evaluate and recommend new technologies or equipment to improve clean room efficiency and production capabilities.
- Drive continuous improvement initiatives in operations, leveraging Lean and Six Sigma methodologies.
About the candidate:
- Bachelor’s degree in Engineering (e.g., Chemical, Mechanical, or Industrial) or a related field.
- 5-7 years of experience in process engineering within clean room manufacturing environments.
- Strong understanding of good manufacturing practices and clean room protocols, including gowning, material handling, and contamination prevention.
- Knowledge of ISO 14644 clean room standards and environmental monitoring practices.
- Proficiency in process simulation and statistical analysis tools (e.g., Minitab, JMP).
- Familiarity with quality management systems (ISO 9001, ISO 13485) and regulatory requirements.
- Strong analytical and problem-solving skills with the ability to manage multiple projects.
- Excellent communication and collaboration skills.
What they offer:
- 25 days annual leave per year in addition to bank holidays.
- Up to 7% employer matched pension contribution.
- Private health insurance from day one plus critical illness cover, income protection and life insurance.
- Give as You Earn and Cycle to Work salary sacrifice schemes.
- The company offers the Enjoy Benefits Nursery Scheme to employees after 3 months, and new parents can benefit from up to 17 weeks fully paid maternity, adoption and shared parental leave, 4 weeks fully paid paternity leave, plus an annual allowance for emergency childcare.
- All employees receive access to Linkedin Learning which offers thousands of courses to support their personal and professional development. The company also runs frequent training sessions on both hard and soft skills.
Manufacturing Process Engineer - Medical Devices employer: CT19
Contact Detail:
CT19 Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manufacturing Process Engineer - Medical Devices
✨Tip Number 1
Familiarise yourself with clean room protocols and good manufacturing practices (GMP). Understanding these standards is crucial for a Manufacturing Process Engineer role, especially in the medical devices sector. You can showcase your knowledge during interviews by discussing specific examples of how you've applied these principles in past roles.
✨Tip Number 2
Highlight your experience with Lean and Six Sigma methodologies. These continuous improvement techniques are highly valued in manufacturing settings. Be prepared to discuss any projects where you successfully implemented these strategies to enhance efficiency or reduce waste.
✨Tip Number 3
Network with professionals in the medical device industry. Attend relevant conferences or workshops to meet people who work in similar roles. This can provide you with insights into the latest trends and challenges in the field, which you can reference in your conversations with potential employers.
✨Tip Number 4
Prepare to discuss your problem-solving skills in detail. The role requires troubleshooting production issues, so think of specific instances where you've identified root causes and implemented effective solutions. This will demonstrate your analytical abilities and readiness to tackle challenges head-on.
We think you need these skills to ace Manufacturing Process Engineer - Medical Devices
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in process engineering, particularly in clean room environments. Emphasise your understanding of GMP requirements and any specific technologies or methodologies you've worked with.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific projects or achievements that demonstrate your skills in continuous improvement and collaboration with cross-functional teams.
Highlight Relevant Skills: Clearly outline your proficiency in process simulation and statistical analysis tools like Minitab or JMP. Also, mention your familiarity with ISO standards and quality management systems, as these are crucial for the role.
Showcase Problem-Solving Abilities: Provide examples of how you've successfully identified root causes of production issues and implemented corrective actions in previous roles. This will demonstrate your analytical skills and ability to manage multiple projects effectively.
How to prepare for a job interview at CT19
✨Understand Clean Room Protocols
Make sure you have a solid grasp of clean room protocols and good manufacturing practices. Be prepared to discuss your experience in maintaining compliance and how you've handled contamination prevention in previous roles.
✨Showcase Continuous Improvement Experience
Highlight any initiatives you've led or been part of that focused on continuous improvement, especially using Lean or Six Sigma methodologies. Companies love candidates who can demonstrate their ability to drive efficiency and enhance processes.
✨Prepare for Technical Questions
Expect technical questions related to process engineering principles and environmental monitoring practices. Brush up on ISO standards relevant to clean rooms and be ready to explain how you've applied these in your past work.
✨Emphasise Collaboration Skills
Since the role involves working with cross-functional teams, be ready to share examples of how you've successfully collaborated with R&D, Quality Assurance, or Supply Chain teams. Strong communication and teamwork skills are key!
