Sr. Manager - Technology Transfer and Process Engineering

Permanent position for a Senior Manager of Technology Transfer and Process Engineering to lead new product introduction and engineering readiness at an FDA-regulated manufacturing site. Lead cross-functional tech transfer teams (R&D, formulation, analytical, packaging, quality, manufacturing and supply chain) to move products and processes from development into commercial production. Manage and develop the Process Engineering group; responsible for scale-up, equipment selection, troubleshooting, optimization and continuous improvement. Serve as engineering readiness lead for a major site expansion capital program and future capacity projects. Translate product and process requirements into equipment, facility, utility and automation specifications; lead design reviews with outside engineering firms, contractors and OEM suppliers. Responsible for installation, commissioning, qualification, startup and handoff to operations, including punch-list closure, spare parts, training and SOPs. Develop capital project scope, engineering estimates, schedules and business cases; feed engineering milestones, risks and dependencies into the program PMO's integrated plan. Build standardized tech transfer and engineering readiness processes to support long-term site growth. BS in Engineering or a related technical discipline. Minimum 7 years of progressive experience in technology transfer, process, manufacturing or project engineering. Experience in an FDA-regulated cGMP manufacturing environment. Proven track record transferring products or processes from development into commercial manufacturing. Experience leading technical staff and cross-functional project teams. Working knowledge of equipment installation, commissioning, qualification, startup and operational handoff. Knowledge of FDA, cGMP, applicable ISO standards, Good Engineering Practice (GEP), design controls, risk management and change control. Familiarity with capital project planning, budgeting and project controls. Capital project, site expansion or new equipment startup experience a plus. MS or MBA and/or PMP or similar engineering certification a plus. Position is eligible for 15% bonus. #J-18808-Ljbffr Engineering Resource Group