Tech Transfer & Process Engineering Lead

Engineering Resource Group; Orangeburg (NY); Vor Ort; USD 170.000 - 230.000; Vollzeit

Benefits dieser Stelle

Bonus eligibility (15%)

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Cross-functional leadership

Technology transfer

Process engineering

Project management

Team leadership

Regulatory compliance

Ausbildung

BS in Engineering

MS or MBA (preferred)

PMP or similar certification (plus)

Jobbeschreibung

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.