Engineer II, MS&T

Experteer Overview In this Engineer II, MS&T role you translate client and development input into cGMP processes and serve as a subject matter expert in biologic upstream and downstream operations. You will lead tech transfer and investigations in a fast-paced, cross-functional setting on the manufacturing floor. The position supports GMP manufacturing of viral vector-based therapies, contributing to clinical and commercial supply. You join a mission-driven team delivering advanced therapies to patients. Compensation / Benefits * Lead MS&T project activities and serve as subject matter expert for cell culture, purification, and fill & finish processes * Lead process and product investigations and author investigation reports * Manage technology transfer projects from Catalent Process Development and external clients into GMP manufacturing * Prepare technology transfer documents, Master Production Records, and SOPs for GMP projects * Coordinate with Program Management to meet project milestones and participate in meetings * Collect and trend process data for client and internal reviews * Train GMP Manufacturing staff on client processes * Evaluate equipment and disposable systems for client projects * Conduct facility fit assessments, process modeling, and Continued Process Verification statistical analysis Tasks * Bachelor in Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3-6 years in pharma/biotech, or Master in same fields with 2+ years * Knowledge of protein and virus manufacturing in a cGMP environment * Experience in cell/microbial culture, protein purification, and fill/finish * Experience with process modeling software such as SuperPro, JMP, MatLab, or Aspen is a plus * On-site manufacturing floor presence and cross-functional collaboration experience Key requirements * medical, dental, and vision benefits effective day one * tuition reimbursement * competitive paid time off and 8 holidays * on-site career development and diverse, inclusive culture

_ milestones and participate in meetings * Collect and trend process data for client and internal reviews * Train GMP Manufacturing staff on client processes * Evaluate equipment and disposable systems for client projects * Conduct facility fit assessments, process modeling, and Continued Process Verification statistical analysis Tasks * Bachelor in Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3-6 years in pharma/biotech, or Master in same fields with 2+ years * Knowledge of protein and virus manufacturing in a cGMP environment * Experience in cell/microbial culture, protein purification, and fill/finish * Experience with process modeling software such as SuperPro, JMP, MatLab, or Aspen is a plus * On-site manufacturing floor presence and cross-functional collaboration experience Key requirements * medical, dental, and vision benefits effective day one * tuition reimbursement * competitive paid time off and 8 holidays * on-site career development and diverse, inclusive culture