Engineer I, MSAT

Role: Process Engineer in Manufacturing Science and Technology (MSAT) supporting GMP manufacturing, technology transfers, and process validation within a biopharma context. Objectives: serve as SME for manufacturing processes, ensure regulatory compliance, and drive continuous process improvements. Responsibilities: provide technical assessments for technology transfers and process changes; author and review technical documentation; troubleshoot GMP manufacturing issues; lead deviation investigations and root-cause analysis; support process validation and data monitoring initiatives; participate in evaluating new technology and process automation; collaborate cross-functionally with Process Development, Manufacturing, Supply Chain, Regulatory Sciences, and Quality to ensure smooth operations and compliance. Requirements: BS/MS in Biochemical/Chemical Engineering, Biotechnology, Chemistry, or Biology; 3+ to 5+ years of related experience in biotech or pharmaceutical manufacturing; strong knowledge of aseptic processing, cell culture, and GMP regulations; hands-on experience with process development, validation, and lifecycle management; familiarity with automated devices like LOVO, Sepax, Rotea, CliniMACs; proven ability to lead investigations, write technical reports, and manage change controls. Preferred: certifications such as Six Sigma Green/Black Belt, Certified Quality Engineer. High-Value: biotechnology products, cGMP manufacturing, process validation, tech transfer, deviation investigation, and process optimization within a highly regulated environment. Work setup involves cross-functional collaboration, on-floor troubleshooting, and documentation support.