Senior Process Engineer

About the role

We are seeking a highly experienced Senior Process Engineer to lead a large-scale Fill/Finish Technology Transfer project within a pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in sterile drug product manufacturing, process validation, and technology transfer, with the ability to independently lead cross-functional teams and drive project execution from planning through commercialization.

Responsibilities

• Lead end-to-end Fill/Finish technology transfer activities.
• Review and assess process documentation, batch records, and technology transfer packages.
• Identify documentation and process gaps and drive timely resolution.
• Develop and implement process control strategies supporting validation and commercial manufacturing.
• Lead engineering, PPQ, validation, and commercial batch execution.
• Develop and own the process validation strategy.
• Provide technical leadership and guidance for validation protocols and reports.
• Collaborate with Manufacturing, Engineering, Quality, Validation, and external clients.
• Serve as the technical lead for successful technology transfer execution.

Requirements

• Extensive experience with Fill/Finish Technology Transfer.
• Strong background in sterile pharmaceutical manufacturing.
• Hands-on experience supporting Engineering, PPQ, Validation, and Commercial batches.
• Expertise in Process Validation and Process Control Strategy.
• Strong understanding of cGMP regulations and pharmaceutical manufacturing.
• Excellent troubleshooting, leadership, and communication skills.

Qualifications

• Drug Product manufacturing experience.
• Experience leading cross-functional technical teams.
• Strong documentation review and technical writing support experience.