Senior Manufacturing Engineer – Cell and Gene Therapy

Newton Colmore Consulting Ltd; United Kingdom; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading medical devices firm based in Cambridge is seeking a Senior Manufacturing Engineer to oversee the transition of products into full-scale manufacturing. The role involves ensuring compliance with ISO standards, leading scaling projects, and collaborating across global teams. Candidates should have a degree in chemical engineering or biotechnology and a strong background in manufacturing engineering. Competitive salary, bonus, and benefits are offered.

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.
• 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 projects that scale up bioreactor and consumable systems.
• Collaborate with internal teams and external partners as a key technical interface.

Skills

Manufacturing engineering

Regulatory documentation

Technical support

Collaboration

Education

Degree in chemical engineering, biotechnology, or related field

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.

You will be responsible for transferring products from development into full-scale manufacture, ensuring quality and compliance with ISO 13485 standards. Your work will include instrument qualification, supplier alignment for CE and UKCA certification, and the creation of robust documentation, including SOPs and Work Instructions. You will collaborate closely with internal teams and external partners, acting as a key technical interface across continents.

We are seeking someone with a strong background in manufacturing engineering within biotech, medical devices, or automation. You will bring hands-on experience in product transfer, regulatory documentation, and customer-facing technical support. A degree in chemical engineering, biotechnology, or a related field is essential, along with a passion for continuous improvement and collaborative problem-solving.

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]. 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.