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Senior Facilities Engineering Manager

Septodont

Cambridge · On-site Full-time Senior 3w ago

About the role

Job Summary

The Senior Facilities Engineering Manager reports to the Director of Engineering & is responsible for operational oversight of all facility-related functions for the manufacturing site. This role provides strategic leadership, risk‑based decision‑making, & cross‑functional oversight to ensure reliable operations, regulatory compliance, and business continuity. Working closely with senior leadership, Operations, Quality, and EHS, the Senior Facilities Engineering Manager leads critical infrastructure strategy, capital planning, and the resolution of high‑impact facility events. This includes managing all facility, utility & energy systems such as HVAC, water systems (WFI, PW), steam, compressed air, and other critical infrastructure. The role also oversees capital improvement projects related to facilities, utilities, energy, and site infrastructure. This leadership ensures compliance with cGMP standards, maintaining critical utilities, all environments & supporting all site operations. The role also represents Facilities Engineering during regulatory inspections and site‑wide initiatives, ensuring that all facility & utility systems meet GMP, safety, and corporate standards

Responsibilities

  • Works with Director of Engineering, SLT & other departments to develop and execute strategies in line with the company’s strategy & objectives, including continuous quality improvement, efficiency improvements & cost-savings.
  • Champion energy conservation & sustainability initiative

Responsibilities

  • Serve as the primary decision‑maker for facilities‑related operational risks, utility interruptions, and infrastructure‑related compliance issues.
  • Act with full authority for Facilities Engineering decisions in the absence of the Director of Engineering.
  • Represent Facilities Engineering in cross‑functional site initiatives, senior leadership discussions, and corporate strategic projects impacting infrastructure, utilities, and energy systems.
  • Act as the key communication conduit between Facilities Engineering and Operations, Quality, EHS, and senior leadership.
  • Lead risk assessments for facility and utility failures, ensuring potential GMP, safety, and operational impacts are fully evaluated and mitigated.
  • Provide expert technical judgment during critical events, ensuring timely escalation and resolution
  • Manage the facility maintenance team to ensure reliable operation and maintenance of HVAC, cleanroom systems, water systems (WFI, RO), steam, compressed air, and other critical utilities.
  • Maintain robust inventory control and cost management for spare parts and consumables related to area
  • Provide direct support for troubleshooting and resolution of facility equipment breakdowns, coordinating internal teams and external service vendors.
  • Ensure timely response to operational needs to minimize downtime and maintain compliance.
  • Serve as the Facilities Engineering lead during regulatory inspections (e.g., FDA, Health Canada), providing documentation, technical explanations, and corrective action plans as required.
  • Ensure facility‑related regulatory commitments are met and communicated to internal and external stakeholders
  • Identify, justify, and implement projects involving facility upgrades, energy conservation, and infrastructure improvements.
  • Lead the response to critical utility or infrastructure failures, coordinating cross‑functional teams and communicating impacts and recovery plans to senior leadership.
  • Oversee emergency preparedness for facility and utility systems, ensuring robust business continuity plans are in place.
  • Execute projects from concept through completion, including feasibility studies, capital budget approval, vendor selection, installation, commissioning, qualification, and handover to operations.
  • Manages the work of outside contractors or trades personnel required for the completion of projects.
  • Forecasts operating costs of the department and directs preparation of budget requests. Directs staff activities in the department, such as recruitment, hiring, performance evaluations, and salary adjustments.
  • Manages process related documentation and ensures departmental records, specifications, SOPs, Master Equipment Files, and all as‑built and master set drawings are kept in compliance with Company, safety, regulation and legal requirements.
  • Manages the performance and development of all direct reports. In conjunction with the Human Resources Department and the Director of Engineering, conducts ER activities.

Qualifications

  • Ensures compliance with GMP guidelines and ensuring that all GMPs

Requirements

  • Ensures compliance with GMP guidelines and ensuring that all GMPs

Responsibilities

  • Works with Director of Engineering, SLT & other departments to develop and execute strategies in line with the company’s strategy & objectives, including continuous quality improvement, efficiency improvements & cost-savings.
  • Champion energy conservation & sustainability initiative
  • Serve as the primary decision‑maker for facilities‑related operational risks, utility interruptions, and infrastructure‑related compliance issues.
  • Act with full authority for Facilities Engineering decisions in the absence of the Director of Engineering.
  • Represent Facilities Engineering in cross‑functional site initiatives, senior leadership discussions, and corporate strategic projects impacting infrastructure, utilities, and energy systems.
  • Act as the key communication conduit between Facilities Engineering and Operations, Quality, EHS, and senior leadership.
  • Lead risk assessments for facility and utility failures, ensuring potential GMP, safety, and operational impacts are fully evaluated and mitigated.
  • Provide expert technical judgment during critical events, ensuring timely escalation and resolution
  • Manage the facility maintenance team to ensure reliable operation and maintenance of HVAC, cleanroom systems, water systems (WFI, RO), steam, compressed air, and other critical utilities.
  • Maintain robust inventory control and cost management for spare parts and consumables related to area
  • Provide direct support for troubleshooting and resolution of facility equipment breakdowns, coordinating internal teams and external service vendors.
  • Ensure timely response to operational needs to minimize downtime and maintain compliance.
  • Serve as the Facilities Engineering lead during regulatory inspections (e.g., FDA, Health Canada), providing documentation, technical explanations, and corrective action plans as required.
  • Ensure facility‑related regulatory commitments are met and communicated to internal and external stakeholders
  • Identify, justify, and implement projects involving facility upgrades, energy conservation, and infrastructure improvements.
  • Lead the response to critical utility or infrastructure failures, coordinating cross‑functional teams and communicating impacts and recovery plans to senior leadership.
  • Oversee emergency preparedness for facility and utility systems, ensuring robust business continuity plans are in place.
  • Execute projects from concept through completion, including feasibility studies, capital budget approval, vendor selection, installation, commissioning, qualification, and handover to operations.
  • Manages the work of outside contractors or trades personnel required for the completion of projects.
  • Forecasts operating costs of the department and directs preparation of budget requests.
  • Directs staff activities in the department, such as recruitment, hiring, performance evaluations, and salary adjustments.
  • Manages process related documentation and ensures departmental records, specifications, SOPs, Master Equipment Files, and all as-built and master set drawings are kept in compliance with Company, safety, regulation and legal requirements.
  • Manages the performance and development of all direct reports.
  • In conjunction with the Human Resources Department and the Director of Engineering, conducts ER activities.

Skills

HVACcGMPEHSFDAHealth CanadaMaster Equipment FilesSOPsWFI

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