Director: Engineering, Facilities and Validation

 Preparedness today, safer tomorrow.

 Emergent is a leading public health company that delivers protective and life-saving solutions to
 communities around the world.  Here, you will join passionate professionals where our culture is informed
 by our values and commitment to protecting and saving lives.

Job Summary

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.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• 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.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

 
Minimum Education, Experience, Skills

• 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.


• Professional Engineer (PE), PMP, or other relevant professional certification preferred.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $196,000 to $237,100. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data.  The salary may also be adjusted based on applicant’s geographic location.  Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*.  Information regarding additional benefits can be found here:  https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does 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 (including transgender status), 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.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.