Process Development Engineer - Fill-Finish - Contract
An experienced Process Engineer or Scientist is required to support drug product process development and commercial support activities at a leading biologics manufacturing site. This role sits within a cross-functional Process Development team focused on formulation and fill-finish operations (vials and pre-filled syringes) including lyophilisation and capping.
Key Responsibilities:
- Act as a technical SME for drug product formulation, aseptic filling, and lyophilisation processes
- Drive investigations and perform impact assessments for deviations, excursions, and change controls
- Lead and support continuous improvement initiatives to optimise process performance
- Provide technical support to New Product Introductions (NPI), including recipe creation, protocol execution, and troubleshooting
- Review and approve GMP documentation such as SOPs, batch records, and technical reports
- Conduct process risk assessments, identify operational gaps, and implement mitigation strategies
- Perform data trend analysis and support troubleshooting of performance issues
Requirements:
- Degree (BSc/MSc/PhD) in Engineering, Science, or related field with relevant experience (6+ years with BSc/MSc or 3+ years with PhD)
- Strong technical background in drug product fill-finish processes (vials, syringes, lyophilisation)
- Experience working in a GMP environment supporting sterile manufacturing operations
- Proven track record in leading or supporting investigations, change controls, and process improvement
- Knowledge of Lean and Six Sigma methodologies (desirable)
- Exposure to NPI and MSAT environments is an advantage
