JOBTITLE:  Facilities Engineering Manager  

LOCATION:  50 Northern Ave., Boston, Massachusetts 02210 

OPENINGS:  1 

DUTIES:  

• Lead engineering efforts across clean utilities, equipment, and infrastructure for multiple sites and functions, spanning all project phases including conceptual design, detailed design, construction, startup, commissioning, validation, and ongoing operations. 

• Facilitate and perform design and technical reviews for complex, regulated capital projects with emphasis on efficiency, compliance, sustainability, and cost-effectiveness. 

• Drive multi-site engineering standardization by authoring specifications, design guidelines, and policies that serve as benchmarks for capital projects and operations.  

• Manage cross-functional teams including in-house staff, scientific partners, and seasonal consultants to execute critical commissioning and validation projects.  

• Perform specialized engineering assessments for advanced manufacturing, QC, and R&D capital equipment with unique expertise in cell and gene therapy (CGT), oral solid dosage (OSD), and medical devices.  

• Ensure alignment with FDA, NFPA, OSHA, EMA, and MHRA requirements, serving as a subject matter expert who interprets evolving regulations and proactively embeds compliance strategies into facility and equipment design.  

• Lead hazard analyses, risk assessments, and safety reviews for pharmaceutical facilities and equipment, applying risk management principles to protect patient safety, ensure product quality, and safeguard operations.  

• Champion sustainability initiatives, driving energy reduction, carbon emissions reduction, and green engineering improvements across facilities and equipment.  

• Integrate digital engineering tools (BIM, Revit) to modernize facility design, optimize performance, and support predictive maintenance.  

• Bridge science, engineering, and business strategy, ensuring facilities and equipment are future-ready and adaptable to evolving scientific and technological advancements.  

• Standardize and transfer engineering best practices across multiple sites, improving efficiency, cost savings, and consistency across diverse modalities.  

• Coordinate critical project documentation, including Engineering Turnover Packages (ETOP), BIM/Revit deliverables, and integration into facility management systems, ensuring long-term operational readiness. 

• Support leadership in shaping the strategic value proposition of Engineering, advancinginnovationand ensuring capital investments align with long-term business and scientific growth objectives.

REQUIREMENTS:   Employer will accept a Bachelor’s degree, or foreign equivalent, in Engineering or a related field and 4 years of experience in the job offered or in a Facilities Engineering Manager-related occupation.  

Position requires demonstrable experience in the following: 

•  Proficient in AutoCAD, Revit, BIM (Building Information Modeling) for facility design, documentation, and integration into facility management systems.  
• Expertise in URS, FAT, SAT, IQ, OQ, and PQ protocols; skilled in commissioning scripts, validation protocols, and turnover packages (ETOP) for GMP-regulated facilities.  
• Advanced application of PHA, HAZOP, and Risk Assessment principles to identify, evaluate, and mitigate risks in pharmaceutical operations.  
• Deep knowledge of FDA, EMA, MHRA, OSHA, NFPA, and ISPE Baseline Guides, with the ability to interpret evolving regulations and embed compliance strategies into design and operations.  
• Specialized expertise in WFI (Water for Injection), Clean Steam, HVAC, Compressed Air, Process Gases, and Purified Water Systems; experienced in capacity modeling, troubleshooting, and system impact assessments.  
• Hands-on experience with CGT (aseptic processing, isolators), OSD (unit operations and continuous processing lines), and medical device assembly and packaging equipment.  
• Support program readiness for commercial launch for all modalities (CGT, OSD, and Medical Device) by managing capital projects efficiently, within budget and schedule.  
• Skilled in equipment specifications for equipment used in OSD and CGT manufacturing sites and integration with facility infrastructure including HVAC, process systems, utilities, qualification and operation in GMP environment.  
• Skilled in MS Project as well as ThinkCell and Smartsheet for scheduling, project execution, and resource management.  
• Expertise in authoring technical standards for multiple sites for equipment (Air Handling Systems, Chillers, and Boilers) and facilities (Clean Rooms, Clean utility Systems, and Clean Process gas Systems).  
• Strong ability to coordinate engineering, R&D, quality, operations, EH&S, and consultants.  
• Ability to review and approve submittals and RFIs from project team.  
• Proficient in Veeva Document Management, Coupa Procurement Management, Procore Construction Management, and Nuvolo Asset Management.  
• Proficient in EnteliWeb Building Management System, Metasys Building Management System, and Viewlinc / Veriteq Environmental Monitoring System.  
• Knowledge of CFR Part 11 Compliance and automation requirements for manufacturing and lab equipment. 

Rate of Pay:  $154274.00 - $177600.00 

CONTACT: Send Resume to [email protected]. Reference 12140.835. EOE.