Senior Manufacturing Engineer - Cell And Gene Therapy

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

Senior Manufacturing Engineer – Cell & Gene Therapy Systems – Cambridge

We are working with a leading medical devices and biotech company, based in Cambridge, to recruit a Senior Manufacturing Engineer who thrives on solving complex technical challenges across global teams. This role offers the opportunity to lead multiple projects that scale up advanced bioreactor and consumable systems, supporting commercial manufacturing across the UK, Europe, and occasionally further afield.

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 creation of robust documentation, including SOPs and Work Instructions.
• Collaborate closely with internal teams and external partners, acting as a key technical interface across continents.

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.
• Degree in chemical engineering, biotechnology, or a related field.
• Passion for continuous improvement and collaborative problem‑solving.

Benefits

• Competitive salary, annual bonus, private healthcare, generous pension contributions.
• Access to a wide range of lifestyle and professional development benefits.
• Flexible working options and a culture that supports both professional and personal growth.

Contact

For more information, please contact Andrew Welsh, Director of Medical Devices, Biotech and Drug Discovery Recruitment at Newton Colmore, on (phone number removed). Alternatively, submit your application and a member of our team will be in touch. Please note that without a CV, we can only provide limited information.