Director of Engineering, Facilities and Validation

About Emergent

Preparedness today, safer tomorrow.

Emergent is a leading public health company dedicated to delivering protective and life-saving solutions to communities around the world. Our culture is deeply informed by our core values and an unwavering commitment to protecting and saving lives. Here, you will join a team of passionate professionals working together to ensure the safety and reliability of critical vaccine supply chains.

About the Role

The Director, Engineering, Facilities & Validation (EFV) serves as a strategic leader for our Canton, MA GMP commercial vaccine Drug Substance manufacturing site. This role is the cornerstone of our operational readiness, ensuring that our facilities, utilities, and equipment are reliable, compliant, and inspection-ready to support safe, high-quality, and uninterrupted commercial supply.

In this position, you will provide hands-on leadership across capital planning, facility lifecycle management, and validation programs. You will act as a key member of the site leadership team, balancing strategic oversight with tactical execution to drive continuous improvement. Your day-to-day involves managing complex infrastructure reliability, leading major shutdowns and turnarounds, and serving as the primary subject matter expert during regulatory inspections. By partnering cross-functionally with Manufacturing, Quality, and Supply Chain, you will help shape the future of our site's capacity and technology transfer capabilities.

Hiring Process

If you are selected for an interview, you will have the opportunity to speak with a Human Resources Partner about our compensation philosophy and available benefits. We look forward to learning more about your experience and how you can contribute to our mission.

Equal Opportunity & Culture

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer that values the diversity of our workforce. We do not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression, sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information, or any other characteristics protected by applicable federal, state, or local law.

We respect your privacy and are committed to maintaining the confidentiality of any information submitted during the application process. Please note that Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search or recruiting agencies not already on our approved agency list.

Work location

Work model: On-site

779, Washington Street, Canton, Norfolk County, Massachusetts, 02021, United States

Canton, Massachusetts

Key Responsibilities

check_circleProvide strategic and operational leadership for Engineering, Facilities, Utilities, Maintenance, and Validation functions
check_circleEnsure sustained compliance and inspection readiness with FDA, EMA, and global GMP regulations
check_circleOwn site infrastructure reliability and lifecycle management including troubleshooting and root cause investigations
check_circleLead site qualification and validation programs for facilities, utilities, equipment, and computerized systems
check_circleDevelop and manage the site capital plan including budget ownership, forecasting, and project delivery
check_circlePlan and coordinate short-term and long-term site shutdowns, turnarounds, and major maintenance windows
check_circlePartner cross-functionally with Manufacturing, Quality, Supply Chain, and EHS to support operational goals
check_circleEstablish and monitor KPIs for EFV performance including safety, compliance, asset reliability, and cost

Requirements

verifiedBachelor's degree in Engineering (Chemical, Mechanical, Electrical, or related discipline) or equivalent technical degree
verifiedMinimum of 15 years of progressive experience in engineering, facilities, and/or validation roles within a GMP biopharmaceutical manufacturing environment
verifiedMinimum of 8–10 years of people leadership experience
verifiedDemonstrated expertise in GMP regulations, validation and qualification practices, and regulatory inspection management
verifiedProven experience leading capital projects and programs
verifiedStrong technical knowledge of GMP utilities (e.g., WFI, clean steam, HVAC), manufacturing equipment, and facility systems
verifiedProfessional Engineer (PE), PMP, or other relevant professional certification preferred

Nice to Have

Advanced degree in Engineering or related discipline. Experience with vaccine and/or biologics drug substance manufacturing. Professional Engineer (PE) or PMP certification.

Company

Emergent BioSolutions

Industry

Biotechnology Research

Headquarters

Gaithersburg, Maryland

Protecting against emerging global health threats.

Emergent BioSolutions is a biotechnology research firm headquartered in Gaithersburg, Maryland, dedicated to developing, manufacturing, and delivering countermeasures against public health threats. For over two decades, the organization has focused on preparing communities for potential biological emergencies, ensuring protections are available when needed most. The company's work centers on creating defenses against scenarios that are hoped never to occur, maintaining readiness for unforeseen challenges. The organization serves public health sectors and government entities by providing critical solutions designed to safeguard populations. Emergent BioSolutions operates with a commitment to transparency and security, explicitly warning candidates about recruitment fraud. The company states it will never request financial commitments from job seekers as a condition of employment. This stance underscores a dedication to ethical hiring practices and the protection of applicants seeking opportunities within the biotechnology industry.

Skills, education and keywords

Skills: GMP, Iq/oq/pq, Wfi, Clean Steam, Hvac, Pe, PMP.

Education: Bachelor's degree in Engineering or equivalent technical degree; Advanced degree preferred.

Frequently asked questions about Director: Engineering, Facilities and Validation at Emergent BioSolutions

What does a Director: Engineering, Facilities and Validation at Emergent BioSolutions do?expand_more

In this Director: Engineering, Facilities and Validation at Emergent BioSolutions role, you will provide strategic and operational leadership for engineering, facilities, utilities, maintenance, and validation functions; ensure sustained compliance and inspection readiness with fda, ema, and global gmp regulations; own site infrastructure reliability and lifecycle management including troubleshooting and root cause investigations; and lead site qualification and validation programs for facilities, utilities, equipment, and computerized systems.

What are the requirements for this Director: Engineering, Facilities and Validation role?expand_more

To qualify for the Director: Engineering, Facilities and Validation at Emergent BioSolutions position, applicants should have: Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, or related discipline) or equivalent technical degree; Minimum of 15 years of progressive experience in engineering, facilities, and/or validation roles within a GMP biopharmaceutical manufacturing environment; Minimum of 8–10 years of people leadership experience; Demonstrated expertise in GMP regulations, validation and qualification practices, and regulatory inspection management; Proven experience leading capital projects and programs; and Strong technical knowledge of GMP utilities (e.g., WFI, clean steam, HVAC), manufacturing equipment, and facility systems.

Where is the Director: Engineering, Facilities and Validation role at Emergent BioSolutions located?expand_more

Director: Engineering, Facilities and Validation at Emergent BioSolutions is based in 779, Washington Street, Canton, Norfolk County, Massachusetts, 02021, United States. This is a on-site role.

Is this Director: Engineering, Facilities and Validation job remote, hybrid, or on-site?expand_more

Emergent BioSolutions has listed this Director: Engineering, Facilities and Validation role as on-site.

How much experience is required for this Director: Engineering, Facilities and Validation role?expand_more

Director: Engineering, Facilities and Validation at Emergent BioSolutions typically requires 15+ years of relevant experience at the executive level.

What skills do you need for the Director: Engineering, Facilities and Validation role at Emergent BioSolutions?expand_more

Key skills for Director: Engineering, Facilities and Validation at Emergent BioSolutions include GMP; Iq/oq/pq; Wfi; Clean Steam; Hvac; Pe; and PMP.

What education is required for Director: Engineering, Facilities and Validation at Emergent BioSolutions?expand_more

Educational requirements for this role: Bachelor's degree in Engineering or equivalent technical degree; and Advanced degree preferred.

What category does the Director: Engineering, Facilities and Validation role belong to?expand_more

Director: Engineering, Facilities and Validation at Emergent BioSolutions is part of the engineering job category on Recrutus.

About Emergent BioSolutions

The organization serves public health sectors and government entities by providing critical solutions designed to safeguard populations. Emergent BioSolutions operates with a commitment to transparency and security, explicitly warning candidates about recruitment fraud. The company states it will never request financial commitments from job seekers as a condition of employment. This stance underscores a dedication to ethical hiring practices and the protection of applicants seeking opportunities within the biotechnology industry.

Browse more roles: All Emergent BioSolutions jobs, engineering jobs on Recrutus.

Director: Engineering, Facilities and Validation

About Emergent

About the Role

Hiring Process

Equal Opportunity & Culture

Work location

Key Responsibilities

Requirements

Nice to Have

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Skills, education and keywords

Frequently asked questions about Director: Engineering, Facilities and Validation at Emergent BioSolutions

About Emergent BioSolutions

Skills Required