Manufacturing Process Engineer - Medical Devices

CT19; Oxford; On-site; GBP 35,000 - 55,000; Full time

Job summary

CT19, a leading start-up in scientific instrumentation, is seeking a skilled Manufacturing Process Engineer in Oxford. This role focuses on clean room operations and driving improvements while ensuring compliance with quality standards. The ideal candidate has extensive process engineering experience and a commitment to excellence in manufacturing settings.

Benefits

25 days annual leave plus bank holidays

Up to 7% employer matched pension contribution

Private health insurance from day one

Cycle to Work salary sacrifice schemes

Fully paid parental leave benefits

Access to Linkedin Learning courses

Qualifications

• 5-7 years of experience in process engineering within clean room environments.
• Strong understanding of good manufacturing practices.
• Knowledge of ISO 14644 clean room standards.

Responsibilities

• Develop, implement, and optimize manufacturing processes for consumables.
• Ensure compliance with regulatory and quality standards.
• Drive continuous improvement initiatives in operations.

Skills

Process optimization

Clean room protocols

Lean methodologies

Six Sigma

Analytical skills

Problem-solving

Education

Bachelor’s degree in Engineering

Tools

Minitab

JMP

Job description

Job Description

An opportunity to join one of the UK’s most successful start-ups in scientific instrumentation and analytics from the last few years. This company have gone from strength to strength in developing and commercialising 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. The ideal candidate will bring a deep understanding of process engineering principles, clean room protocols, and the ability to drive continuous improvement in a demanding manufacturing setting.

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.