Sr. Manager – Technology Transfer and Process Engineering

Engineering Resource Group; Orangeburg (NY); Sur place; USD 170 000 - 230 000; Plein temps

Avantages offerts par ce poste

Bonus eligibility (15%)

Résumé du poste

Engineering Resource Group is seeking a Senior Manager of Technology Transfer and Process Engineering to lead the transfer of products and processes from development to commercial production at an FDA-regulated site.

You will manage the Process Engineering group, drive scale-up, equipment selection, commissioning, qualification, and handoffs to operations. This role requires a strong track record in regulatory environments and cross-functional leadership.

Qualifications

• BS in engineering required.
• Minimum 7 years of progressive experience in technology transfer, process, manufacturing or project engineering.
• Experience in FDA-regulated cGMP manufacturing.
• Proven track record leading cross-functional teams.
• Knowledge of FDA, cGMP, ISO standards, GEP, design controls, risk management and change control.

Responsabilités

• Lead cross-functional tech transfer teams to move products and processes from development to commercial production.
• Manage and develop the Process Engineering group; scale-up, equipment selection, troubleshooting, optimization and continuous improvement.
• Serve as engineering readiness lead for site expansion capital programs and capacity projects.
• Translate product and process requirements into equipment, facility, utility and automation specs; lead design reviews with external firms and OEMs.
• 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 milestones and risks into PMO plans.
• Build standardized tech transfer and engineering readiness processes to support long-term site growth.

Connaissances

Cross-functional leadership

Technology transfer

Process engineering

Project management

Team leadership

Regulatory compliance

Formation

BS in Engineering

MS or MBA (preferred)

PMP or similar certification (plus)

Description du poste

• 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.