Director: Engineering, Facilities and Validation
About The Position
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. This role ensures reliable, compliant, and inspection-ready facilities and equipment that enable safe, high-quality, and uninterrupted commercial supply. The Director of EFV serves as a key member of the site leadership team, providing strategic and hands-on leadership across capital planning and execution, facility lifecycle management, qualification and validation programs, operational readiness, and continuous improvement. The role is responsible for capital expenditure (CapEx) governance, short- and long-term shutdown planning and execution, site infrastructure reliability, remediation and improvement initiatives, and compliance with FDA, EMA, and global GMP requirements.
Requirements
- Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related discipline) or equivalent technical degree; advanced degree preferred.
- 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.
- Ability 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.
Nice To Haves
- Professional Engineer (PE), PMP, or other relevant professional certification preferred.
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.
Benefits
- Comprehensive benefits package
- Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
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What This Job Offers
Job Type
Full-time
Career Level
Director
