Senior Manufacturing Engineer - Cell & Gene Therapy - Cambridge

Newton Colmore; Cambridge; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading medical devices and biotech company in Cambridge is seeking a Senior Manufacturing Engineer to solve complex technical challenges. This role involves transferring products from development to full-scale manufacture and ensuring quality compliance. Ideal candidates will have a background in biotech, strong project management skills, and a relevant degree. The position offers a competitive salary and benefits including private healthcare and flexible working options.

Benefits

Competitive salary

Annual bonus

Private healthcare

Generous pension contributions

Professional development benefits

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.

Responsibilities

• Transfer products from development into full-scale manufacture, ensuring quality and ISO 13485 compliance.
• Lead instrument qualification and supplier alignment for CE and UKCA certification.
• Create robust documentation, including SOPs and Work Instructions.
• Collaborate with internal teams and external partners as a key technical interface across continents.
• Manage multiple projects scaling up bioreactor and consumable systems for commercial manufacturing.

Skills

Manufacturing engineering

Product transfer

Regulatory documentation

Customer-facing technical support

Continuous improvement

Collaborative problem-solving

Education

Degree in chemical engineering, biotechnology, or related field

Job description

Overview

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 ISO 13485 compliance.
• Lead instrument qualification and supplier alignment for CE and UKCA certification.
• Create robust documentation, including SOPs and Work Instructions.
• Collaborate with internal teams and external partners as a key technical interface across continents.
• Manage multiple projects scaling up bioreactor and consumable systems for commercial manufacturing in the UK, Europe, and beyond.

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

This is an opportunity to join a company that is redefining how biotechnologies and medical devices are manufactured. You will be part of a team that values technical hobbies, mentoring, and global impact, with flexible working options and a culture that supports both professional and personal growth.

In return, you will receive a competitive salary, annual bonus, private healthcare, generous pension contributions, and access to a wide range of lifestyle and professional development benefits.

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.