Process Development Engineer

Process Development EngineerLocation: North Carolina Long-Term Project Responsibilities:Lead technology transfer activities for new and commercial biologics.Support downstream manufacturing process lifecycle management.Coordinate process validation, scale-up, and new product introduction (NPI) activities.Execute process improvement initiatives and provide technical support to manufacturing operations.Investigate deviations, CAPAs, and change controls while ensuring GMP compliance.Implement and support Process Analytical Technology (PAT) and process monitoring initiatives.Analyse manufacturing data, identify process trends, and support continuous process verification.Author and review validation protocols, technical reports, SOPs, investigations, and other GMP documentation.Collaborate with cross-functional teams, including Manufacturing, Quality, Engineering, Validation, and Process Development.Required Qualifications:Bachelor's degree in engineering, life sciences, biochemistry, biology, or a related scientific discipline.4+ years of experience in pharmaceutical or biopharmaceutical manufacturing.2+ years of experience in MSAT or Technology Transfer.Experience with Downstream Processing and Process Validation.Strong understanding of GMP regulations, FDA compliance, CAPA, change control, and investigations.Experience with process analytics, data trending, statistical analysis, and continuous improvement.Proficiency with Microsoft Office and SAP.