Facilities Engineering Manager

Job Title

Facilities Engineering Manager

50 Northern Ave., Boston, Massachusetts 02210

• 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, advancing innovation and ensuring capital investments align with long‑term business and scientific growth objectives.

• Bachelor's degree in Engineering or related field and 4 years of experience in a Facilities Engineering Manager‑related occupation.
• Proficient in AutoCAD, Revit, BIM 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, 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, 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 Think Cell and Smartsheet for scheduling, project execution, and resource management.
• Expertise in…