Senior Tech Transfer & Process Engineering Leader

Engineering Resource Group; Orangeburg (NY); Vor Ort; USD 150.000 - 210.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Technology Transfer

Process Engineering

Leadership

Project Management

Cross-Functional Collaboration

FDA cGMP compliance

Ausbildung

BS in Engineering

MS or MBA (plus PMP)

Tools

Qualification & Commissioning

CAPEX / Project Controls

Jobbeschreibung

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