Facilities Engineering Manager

Vertex Inc. • Boston, MA

4d • $118,400 - $177,600 • Hybrid

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• medical, dental and vision benefits
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• educational assistance programs including student loan repayment
• a generous commuting subsidy
• matching charitable donations
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager