Senior Manufacturing Engineer - Cell and Gene Therapy in Cambridge)

Newton Colmore Consulting; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading medical devices firm in Cambridge is seeking a Senior Manufacturing Engineer. This role involves solving complex technical challenges and transferring products from development to full-scale manufacture, ensuring compliance with ISO 13485 standards. The ideal candidate will have a degree in chemical engineering or biotechnology and expertise in manufacturing engineering. The company offers a competitive salary, annual bonus, private healthcare, and opportunities for professional and personal growth.

Benefits

Competitive salary

Annual bonus

Private healthcare

Generous pension contributions

Lifestyle and professional development benefits

Qualifications

• Strong background in manufacturing engineering within biotech or medical devices.
• Hands-on experience in product transfer and ensuring regulatory compliance.
• Passion for continuous improvement and collaboration.

Responsibilities

• Transfer products from development to full-scale manufacture.
• Ensure quality and compliance with ISO 13485 standards.
• Collaborate with internal teams and external partners.

Skills

Manufacturing engineering

Regulatory documentation

Customer-facing technical support

Collaborative problem-solving

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.

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.