Senior Process Engineer

Join a leading biopharma manufacturer as a hands-on Process Development contractor supporting sterile syringe products. You'll drive NPIs, tech transfers, and on-floor troubleshooting across both small- and large-molecule drug products.

What You'll Do

• Lead NPIs and lifecycle changes for syringe formats (SF01-SF03), serving as the PD SME from transfer through commercialisation.
• Provide technical expertise in formulation, filling, freeze/thaw, inspection, and sterile operations-supporting both NPI and commercial manufacturing.
• Author and contribute to regulatory filings and respond to regulator queries.
• Lead process characterisation, validation (incl. PPQ), and risk assessments; drive CAPA and continuous improvement.
• Partner with Operations, Engineering, Quality and vendors to resolve deviations, troubleshoot equipment/process issues, and strengthen validated processes.

What You'll Need

• Degree in Science/Engineering/Quality (BSc + 5 yrs, MSc + 3 yrs, or equivalent experience).
• Strong understanding of cGMP and global regulatory expectations.
• Proven problem-solving skills and clear, concise communication.