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 manufacturingServe as the technical owner for assigned processes, driving optimization, troubleshooting, and lifecycle managementEvaluate and improve process robustness, scalability, and compliance with regulatory expectationsAuthor and review process validation protocols, change controls, and deviation investigationsPartner cross-functionally with Manufacturing, Quality, and Regulatory teams to ensure seamless executionRepresent technical operations in client-facing meetings, providing expertise and leadership in discussionsMentor junior engineers and provide technical guidance across the organizationQualifications:Bachelor’s degree required (advanced degree preferred) in Engineering or related field10–15+ years of experience in pharmaceutical manufacturing within a CDMO/CMO setting strongly preferredDeep 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 environmentsProven experience managing complex projects and multiple concurrent programsDemonstrated leadership skills with the ability to influence cross-functional teamsFamiliarity with statistical analysis and continuous improvement methodologies is a plus