Senior Cell & Gene Therapy Manufacturing Engineer

Newton Colmore; Cambridge; On-site; GBP 50,000 - 75,000; Full time

Job summary

A leading medical devices and biotech company in Cambridge is seeking a Senior Manufacturing Engineer. This role involves leading projects to scale up bioreactor and consumable systems for commercial manufacturing, ensuring compliance with ISO standards. The ideal candidate will have a strong background in manufacturing engineering within biotech, and possess hands-on experience in product transfer and regulatory documentation. Benefits include a competitive salary, annual bonus, and flexible working options.

Benefits

Competitive salary

Annual bonus

Private healthcare

Generous pension contributions

Access to lifestyle and professional development benefits

Flexible working options

Qualifications

• Strong background in manufacturing engineering within biotech, medical devices, or automation.
• Hands-on experience in product transfer, regulatory documentation, and customer-facing technical support.
• Passion for continuous improvement and collaborative problem-solving.

Responsibilities

• Transfer products from development into full-scale manufacture, ensuring quality and compliance with ISO 13485 standards.
• Lead instrument qualification, supplier alignment for CE and UKCA certification, and robust documentation creation.
• Collaborate closely with internal teams and external partners, acting as a key technical interface.

Skills

Manufacturing engineering

Product transfer

Regulatory documentation

Technical support

Continuous improvement

Collaborative problem-solving

Education

Degree in chemical engineering

Degree in biotechnology

Related field degree

Job description

A leading medical devices and biotech company in Cambridge is seeking a Senior Manufacturing Engineer. This role involves leading projects to scale up bioreactor and consumable systems for commercial manufacturing, ensuring compliance with ISO standards. The ideal candidate will have a strong background in manufacturing engineering within biotech, and possess hands-on experience in product transfer and regulatory documentation. Benefits include a competitive salary, annual bonus, and flexible working options.