Important: Visa sponsorship is not available for this role. Applicants must already have the right to work in the UK. Prior experience with Continued Process Verification (CPV) / Process Validation is essential.
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Title: Technical Associate II, MSAT (CPV / Process Validation SME)
Location: Stevenage, UK (occasional London)
Working Pattern: On-site 5 days per week. Fixed shifts also available if preffered
About the Company
A leading biotechnology company at the forefront of advanced cell and gene therapy. With a state-of-the-art site in Stevenage, they are delivering commercial manufacturing in the UK and already have products approved in the US. Their approach combines computational design with modular T-cell programming to develop adaptable therapies for cancer and autoimmune disease.
The Opportunity
This is an expansion role within MSAT, focused on process validation and CPV. You’ll act as the subject matter expert for validation activities, supporting GMP manufacturing and technology transfer. It’s a hands-on, fully on-site role offering exposure to ATMP manufacturing and commercial readiness in a fast-growing biotech.
Key Responsibilities
* Act as SME for process validation and CPV, supporting routine GMP manufacturing.
* Provide floor and on-call support during tech transfer and batch execution.
* Conduct product impact assessments, root cause analysis, and CAPAs.
* Review and maintain GMP documentation including batch records, sampling plans, and material specifications.
* Contribute to CPV data entry, trending, and verification.
* Support technology transfer of new products into GMP.
* Represent MSAT in cross-functional teams and support process improvements.
Requirements
Essential:
* 2–5 years’ experience in GMP manufacturing.
* Direct experience with process validation or CPV.
* Strong technical writing, communication, and problem-solving skills.
* Ability to work independently and cross-functionally in a fast-paced environment.
* Fully on-site availability in Stevenage.
Preferred:
* Experience in ATMP, biologics, or other regulated manufacturing.
* Background in technology transfer or process/product lifecycle management.
* Degree in science, engineering, or equivalent practical experience.
* Familiarity with QMS, deviations, CAPAs, and regulatory requirements.
* Exposure to aseptic processing, cell culture, or downstream processing.
* Experience with data analysis tools and continuous improvement methodologies.