Technical Associate II, MSAT (CPV / Process Validation SME)
Location: Stevenage, UK
Working pattern: Fully on-site, 5 days a week. 
Sponsorship: Not available at this level.

About the Company

We are working with a pioneering biopharmaceutical organisation at the forefront of advanced therapies for cancer and autoimmune diseases. With a state-of-the-art facility in Stevenage, they are expanding their MSAT team to support commercial readiness and innovative manufacturing approaches.

The Opportunity

This is an SME role for Process Validation (PV) and Continued Process Verification (CPV) within MSAT, supporting GMP manufacturing, validation, and tech transfer activities. It is a fully on-site, hands-on position offering exposure to commercial operations and ATMP manufacturing in a high-growth biotech environment.

Key Responsibilities

• Provide frontline SME support for manufacturing processes and batch execution.
• Deliver on-call and floor support during tech transfer and routine manufacturing.
• Perform product impact assessments, root cause analysis, and CAPAs.
• Review and maintain GMP documentation including batch records, sampling plans, and material specs.
• Support technical change, equipment implementation, and process improvements.
• Contribute to CPV data entry, trending, and verification.
• Represent MSAT in cross-functional teams.
• Support technology transfer of new products into GMP.

What We’re Looking For

• 2–5 years’ GMP manufacturing experience.
• Experience acting as SME in process validation or CPV.
• Comfort in a fully on-site, shift-based role in Stevenage.
• Exposure to tech transfer, deviations, or CAPAs in GMP.
• Experience in ATMP or biologics manufacturing (preferred).

Skills and Competencies

Essential:

• 2–5 years’ GMP manufacturing experience.
• Knowledge and understanding of GMP.
• Excellent technical writing, communication, and interpersonal skills.
• Ability to work independently and cross-functionally.
• Strong problem-solving and collaborative mindset.

Preferred:

• Equipment and/or process experience in GMP.
• ATMP manufacturing experience.
• Technology transfer and lifecycle management.
• Degree in science, engineering, or related.
• Understanding of regulatory policies.
• QMS, deviations, and CAPA management.
• Lean/Six Sigma or operational excellence tools.
• Exposure to biotech, pharma, or cell/gene therapy.
• Aseptic processing, cell culture, downstream processing.
• Data analysis tools and automation projects.

Technical Associate II, MSAT (CPV / Process Validation SME)
Location: Stevenage, UK
Working pattern: Fully on-site, 5 days a week. Option for fixed shifts if preferred (Sunday–Wednesday or Wednesday–Saturday, early or late schedule).
Sponsorship: Not available at this level.

About the Company

We are working with a pioneering biopharmaceutical organisation at the forefront of advanced therapies for cancer and autoimmune diseases. With a state-of-the-art facility in Stevenage, they are expanding their MSAT team to support commercial readiness and innovative manufacturing approaches.

The Opportunity

This is an SME role for Process Validation (PV) and Continued Process Verification (CPV) within MSAT, supporting GMP manufacturing, validation, and tech transfer activities. It is a fully on-site, hands-on position offering exposure to commercial operations and ATMP manufacturing in a high-growth biotech environment.

Key Responsibilities

• Provide frontline SME support for manufacturing processes and batch execution.
• Deliver on-call and floor support during tech transfer and routine manufacturing.
• Perform product impact assessments, root cause analysis, and CAPAs.
• Review and maintain GMP documentation including batch records, sampling plans, and material specs.
• Support technical change, equipment implementation, and process improvements.
• Contribute to CPV data entry, trending, and verification.
• Represent MSAT in cross-functional teams.
• Support technology transfer of new products into GMP.

What We’re Looking For

• 2–5 years’ GMP manufacturing experience.
• Experience acting as SME in process validation or CPV.
• Comfort in a fully on-site, shift-based role in Stevenage.
• Exposure to tech transfer, deviations, or CAPAs in GMP.
• Experience in ATMP or biologics manufacturing (preferred).

Skills and Competencies

Essential:

• 2–5 years’ GMP manufacturing experience.
• Knowledge and understanding of GMP.
• Excellent technical writing, communication, and interpersonal skills.
• Ability to work independently and cross-functionally.
• Strong problem-solving and collaborative mindset.

Preferred:

• Equipment and/or process experience in GMP.
• ATMP manufacturing experience.
• Technology transfer and lifecycle management.
• Degree in science, engineering, or related.
• Understanding of regulatory policies.
• QMS, deviations, and CAPA management.
• Lean/Six Sigma or operational excellence tools.
• Exposure to biotech, pharma, or cell/gene therapy.
• Aseptic processing, cell culture, downstream processing.
• Data analysis tools and automation projects.