Facilities Engineering Manager

JOBTITLE:FacilitiesEngineering Manager

LOCATION:50Northern 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 uniqueexpertisein 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 designoptimizeperformance 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.

• Standardizeand 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 growthobjectives.

REQUIREMENTS:Employer will accept aBachelorsdegree or foreign equivalent in Engineeringor a related field and4years of experience in the job offered or ina 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.
• Expertisein 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 toidentify 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.
• Specializedexpertisein 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 utilitiesqualificationand operation in GMP environment.
• Skilledin MS Project as well asThinkCelland Smartsheet for scheduling project execution and resource management.
• Expertisein 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 fromprojectteam.
• Proficientin Veeva Document Management Coupa Procurement Management Procore Construction Management and Nuvolo Asset Management.
• Proficient inEnteliWebBuilding Management System Metasys Building Management System andViewlinc/VeriteqEnvironmental Monitoring System.
• Knowledge of CFR Part 11 Compliance and automation requirements for manufacturing and lab equipment.

Rate ofPay:$154274.00- $177600.00

CONTACT:Send Resume tofuturetalent@.Reference12140.835. EOE.