Director: Engineering, Facilities and Validation

About the role

The Director, Engineering, Facilities & Validation (EFV) is accountable for the end-to-end leadership and performance of Engineering, Facilities, Utilities, Maintenance, Automation (as applicable), and Validation functions for the Canton, MA GMP commercial vaccine Drug Substance (DS) manufacturing site.

Responsibilities

• Provide strategic and operational leadership for all Engineering, Facilities, Utilities, Maintenance, and Validation activities supporting a GMP commercial vaccine DS manufacturing facility.
• Ensure sustained compliance and inspection readiness with applicable GMP regulations, including FDA, EMA, and global regulatory expectations; serve as an EFV subject matter expert during regulatory inspections and audits.
• Own site infrastructure reliability and lifecycle management, including facility and equipment troubleshooting, root cause investigations, remediation, and implementation of long-term reliability improvements.
• Lead site qualification and validation programs, including facilities, utilities, equipment, and computerized systems, ensuring compliant execution of IQ/OQ/PQ, periodic requalification, and change management.
• Develop, manage, and execute the site capital plan, including 3- to 5-year master planning, annual CapEx prioritization, budget ownership, spend tracking, forecasting, and delivery of projects on time and within budget.
• Plan and coordinate short-term and long-term site shutdowns, turnarounds, and major maintenance windows to support safe execution, minimal supply impact, and effective return to operations.
• Partner cross-functionally with Manufacturing, Quality, Supply Chain, EHS, MSAT, and Regulatory to support operational goals, technology transfers, process improvements, and capacity expansion.
• Establish and monitor KPIs for EFV performance, including safety, compliance, asset reliability, cost, schedule adherence, and continuous improvement.
• Build, develop, and lead a high-performing EFV organization, ensuring appropriate capability, capacity, succession planning, and technical development.
• Align site EFV practices with enterprise standards while ensuring site-specific risks and business needs are addressed; collaborate with external contractors, vendors, and engineering firms as required.
• Serve as primary owner for EFV-related risk management, including aging facilities, obsolescence, compliance gaps, and business continuity threats.

Requirements

• Minimum of 15 years of progressive experience in engineering, facilities, and/or validation roles within a GMP biopharmaceutical manufacturing environment; vaccine and/or biologics drug substance experience strongly preferred.
• Minimum of 8–10 years of people leadership experience, including management of managers and cross-functional teams.
• Demonstrated expertise in GMP regulations, validation and qualification practices, and regulatory inspection management for commercial manufacturing facilities.
• Proven experience leading capital projects and programs, including budget ownership, spend tracking, risk management, and delivery within regulated environments.
• Strong technical knowledge of GMP utilities (e.g., WFI, clean steam, HVAC), manufacturing equipment, and facility systems supporting biologics production.
• Able to operate effectively at both strategic and tactical levels in a fast-paced, highly regulated manufacturing environment.
• Excellent leadership, communication, and stakeholder management skills, with the ability to influence across functions and at all organizational levels.
• Strong business acumen, analytical skills, and demonstrated ability to make risk-based decisions.
• Professional Engineer (PE), PMP, or other relevant professional certification preferred.

Qualifications

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related discipline) or equivalent technical degree; advanced degree preferred.
• Ability to operate effectively at both strategic and tactical levels in a fast-paced, highly regulated manufacturing environment.
• Strong business acumen, analytical skills, and demonstrated ability to make risk-based decisions.
• Professional Engineer (PE), PMP, or other relevant professional certification preferred.

Skills

• Strategic and operational leadership for Engineering, Facilities, Utilities, Maintenance, and Validation activities.
• Compliance and inspection readiness with GMP regulations.
• Site infrastructure reliability and lifecycle management.
• Leadership of site qualification and validation programs.
• Capital project management and delivery.
• Facility and equipment troubleshooting, root cause investigations, and remediation.
• Long-term reliability improvements.
• Collaboration with cross-functional teams.
• Development and monitoring of KPIs.
• Building and leading a high-performing EFV organization.
• Risk management, including aging facilities, obsolescence, compliance gaps, and business continuity threats.

Benefits

Emergent offers a comprehensive benefits package, including U.S. Base Pay Ranges and Benefits Information as detailed in the job posting.