Sr Process Engineer (Tech Transfer)

About the role

I am looking for a Senior Process Engineer to lead technology transfer and process validation activities for sterile injectable manufacturing programs. This position will support the transfer of new products and processes into GMP commercial manufacturing, including manufacturing readiness, engineering batches, PPQ, and technical troubleshooting.

Responsibilities

• Lead technology transfer for sterile injectable and aseptic manufacturing processes.
• Develop and execute transfer plans, validation protocols, PPQ protocols, reports, risk assessments, and gap assessments.
• Support engineering, demonstration, qualification, and PPQ batches.
• Define critical process parameters, critical quality attributes, sampling plans, and acceptance criteria.
• Support aseptic filling, formulation, compounding, sterile filtration, sterilization, and lyophilization processes.
• Investigate process deviations and support root-cause analysis, CAPA, and change controls.
• Partner with MSAT, Manufacturing, Quality, Validation, Engineering, and Regulatory teams.
• Track project timelines, technical risks, manufacturing readiness, and transfer deliverables.
• Ensure compliance with cGMP, FDA, EU Annex 1, and process validation requirements.

Requirements

• Bachelor's degree in Engineering or a related scientific discipline.
• 5-10+ years of sterile injectable or aseptic pharmaceutical manufacturing experience to include:
  • Sterile injectables, biologics, vaccines, or parenteral drug products
  • Vial or syringe filling, formulation, compounding, sterile filtration, or lyophilization
  • Product transfers between manufacturing sites, CMOs, or CDMOs
  • Continued process verification, statistical trending, and commercial manufacturing support
• Hands-on experience leading technology transfer and process validation/PPQ.
• Experience authoring and executing protocols, reports, risk assessments, deviations, and change controls.
• Strong knowledge of GMP manufacturing, validation lifecycle practices, and sterile processing.
• Strong technical writing, troubleshooting, project coordination, and cross-functional leadership skills.