Process Engineer

Role: Process Engineer specializing in technology transfer for biopharmaceutical manufacturing, supporting the seamless transfer of processes between development, clinical, and commercial sites. Responsibilities include conducting technical gap assessments, developing transfer strategies, supporting process characterization and validation, and ensuring GMP compliance. The role entails designing and reviewing process descriptions, defining CPPs/KPPs/CQAs, troubleshooting, and supporting single-use systems deployment. It requires cross-functional collaboration with Process Development, Manufacturing, Engineering, Validation, and Quality teams, often involving external partners. The engineer will lead risk assessments, facilitate CQV activities, and contribute to regulatory readiness. Location is flexible with up to 100% travel depending on project needs. Qualifications include a bachelor’s in Engineering, Life Sciences, or related field with at least 5+ years of experience in pharmaceutical/biotech manufacturing, particularly in process transfer, validation, or lifecycle management. Experience with upstream/downstream processes, SUS systems, and process characterization is required. Knowledge of GMP, validation principles, and risk management, along with strong technical documentation, problem-solving, and stakeholder influencing skills, is essential. Experience working with CDMOs/CMOs is preferred. The role offers remote or hybrid work options, competitive compensation, and benefits, with a focus on fostering a positive work environment within a regulated, fast-paced biopharma setting.