Process Engineer

My client is looking for a Process Engineer II to join our Manufacturing Sciences and Technology (MSAT) team. In this role, you’ll play a key part in assessing, transferring, and supporting new manufacturing processes that enable both clinical and commercial production of advanced therapies. Key Responsibilities Act as the Downstream technical expert (clarification, chromatography, TFF, sterile fill/finish) for viral vector manufacturing within the MSAT team. Serve as Technology Transfer Technical Lead for cross-functional teams. Lead the introduction of new manufacturing processes and methods to support clinical and commercial manufacturing of multiple cell and gene therapy drug substances and products. Drive information transfer and gap assessments for new process and method transfers. Support drafting and review of MSAT and Manufacturing documentation, with strong understanding of equipment, critical process parameters, and in-process testing. Lead facility fit assessments of manufacturing processes within production suites, using FMEA or similar risk-based tools to troubleshoot process issues. Author and execute tech transfer plans, engineering studies, risk assessments, technical reports, change controls, and process validation plans/protocols. Provide guidance on documentation of events and deviations during cGMP manufacturing. Support onboarding of new process equipment. Contribute to additional activities as required by management. Requirements 3+ years’ experience in a technical engineering role or related area (or an equivalent combination of education and experience). 3+ years’ experience in the pharmaceutical or biologics industry in process development or manufacturing operations. Experience delivering special projects focused on operational process improvement. Strong leadership, relationship-building, and organisational skills. Willingness and ability to learn and adapt across different areas within MSAT. Knowledge of cGMP requirements for bioprocess drug substance manufacturing. Experience in bioprocess drug substance process development and cGMP manufacturing. Experience with monoclonal antibody production and purification is an advantage. Technical understanding of upstream and downstream operations, including equipment and processes such as disposable technologies, clarification, chromatography skids, TFF systems, formulation, and final fill. Looking forward to speaking with you! Seniority level Mid-Senior level Employment type Full-time Job function Engineering and Manufacturing Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Chemical Manufacturing Wilmington, NC $86,000.00-$132,550.00 7 months ago Hickory, NC $83,750.00-$115,156.00 3 weeks ago Wilson, NC $88,000.00-$132,000.00 2 weeks ago Salem, NC $130,000.00-$170,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr