Technical Associate (CPV)

Blackfield Associates are supporting a leading biopharmaceutical manufacturing organisation, who are looking for a motivated, detail-driven MSAT Technical Associate to join their Manufacturing Science and Technology (MSAT) team. In this hands-on role, you’ll support process validation and Continued Process Verification (CPV) for cutting-edge cell and gene therapy manufacturing.

Working closely with Process Development, Manufacturing, Quality Assurance, and Quality Control, you’ll help ensure processes are robust, compliant, and consistently delivering high-quality products.

What You’ll Do

• Serve as a Subject Matter Expert (SME), providing technical and scientific support for manufacturing processes.
• Support technology transfer and routine manufacturing with on-the-floor and on-call assistance.
• Perform root cause analysis, product impact assessments, and implement corrective/preventive actions.
• Contribute to risk assessments, process control strategies, and commercial readiness activities.
• Review manufacturing documentation, sampling plans, and material specifications.
• Support evaluation and GMP implementation of new equipment and materials.
• Assist with process improvements, change control activities, and data analysis for CPV.
• Represent MSAT in cross-functional projects and teams.
• Participate in technology transfer of new products into GMP manufacturing.

What We’re Looking For

Essential:

• 2–5 years’ experience in GMP manufacturing.
• Strong understanding of Good Manufacturing Practices.
• Excellent technical writing, problem-solving, and cross-functional collaboration skills.
• Ability to make data-driven decisions in a fast-paced environment.

Preferred:

• Experience in Advanced Therapy Medicinal Product (ATMP) manufacturing.
• Background in technology transfer, lifecycle management, and process improvements.
• Knowledge of regulatory policies, Quality Management Systems, Lean/Six Sigma principles.
• Hands-on experience with aseptic processing, cell culture, and downstream processing.
• Familiarity with data analysis tools, automation projects, and operational excellence initiatives.