Sr. Manager - Technology Transfer and Process Engineering

Engineering Resource Group; Orangeburg (NY); On-site; USD 150,000 - 210,000; Full time

Job summary

Engineering Resource Group is seeking a Senior Manager of Technology Transfer and Process Engineering to lead new product introduction and engineering readiness at an FDA-regulated site in New York. You will head cross-functional tech transfer teams to move products from development into commercial production and guide the Process Engineering group through scale-up and qualification activities.

The role includes ownership of installation, commissioning, qualification, startup, and handoff to

Qualifications

• BS in Engineering or 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 from development into manufacturing.
• Experience leading technical staff and cross-functional project teams.

Responsibilities

• Lead cross-functional tech transfer teams (R&D, formulation, analytical, packaging, quality, manufacturing, supply chain) to move products 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.

Skills

Technology Transfer

Process Engineering

Leadership

Project Management

Cross-Functional Collaboration

FDA cGMP compliance

Education

BS in Engineering

MS or MBA (plus PMP)

Tools

Qualification & Commissioning

CAPEX / Project Controls

Job description

• 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.