Principal Process Engineer

I am working with an exciting client who are Seeking a senior-level process engineering expert to lead technical transfer, process optimization, and manufacturing support in a fast-paced, GMP-regulated pharmaceutical environment. This individual will act as a site-wide SME, supporting multiple products and driving process excellence from development through commercial production.

Key Responsibilities:

• Lead and execute end-to-end tech transfer activities for multiple products, ensuring smooth scale-up into manufacturing
• Serve as the technical owner for assigned processes, driving optimization, troubleshooting, and lifecycle management
• Evaluate and improve process robustness, scalability, and compliance with regulatory expectations
• Author and review process validation protocols, change controls, and deviation investigations
• Partner cross-functionally with Manufacturing, Quality, and Regulatory teams to ensure seamless execution
• Represent technical operations in client-facing meetings, providing expertise and leadership in discussions
• Mentor junior engineers and provide technical guidance across the organization

Qualifications

• Bachelor’s degree required (advanced degree preferred) in Engineering or related field
• 10–15+ years of experience in pharmaceutical manufacturing within a CDMO/CMO setting strongly preferred
• Deep expertise in sterile injectable manufacturing, including aseptic processing (small molecule and/or biologics)
• Strong background in process engineering, tech transfer, and validation in FDA-regulated environments
• Proven experience managing complex projects and multiple concurrent programs
• Demonstrated leadership skills with the ability to influence cross-functional teams
• Familiarity with statistical analysis and continuous improvement methodologies is a plus