Manager, Facilities Maintenance
Listed on 2026-08-08
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Quality Assurance - QA/QC
Industrial Maintenance, Regulatory Compliance Specialist, Quality Engineering
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radio conjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radio conjugate manufacturing facility to meet the demand for our growing pipeline of RCs.
Position Overview:Reporting to the Director, Site Operations, the Manager, Facilities Maintenance is responsible for coordinating maintenance and reliability of infrastructure, utilities, and building systems across GMP and non‑GMP environments. They also lead metrology, automation, and sanitation services to ensure the site operates safely, compliantly, and efficiently. The role leads all aspects of facility equipment management, including preventive maintenance, troubleshooting, emergency repairs, and operational support.
Collaborating with multiple departments—including Manufacturing team, Engineering, Quality, Laboratory, Vivarium, IT, Health and Safety, McMaster Facilities, sanitation team, and external contractors—the position ensures facility systems and cleaning programs meet regulatory, operational, and business requirements while supporting uninterrupted site operations in Hamilton, Ontario. The Manager is also responsible for coordinating the site's metrology and calibration activities. They ensure all GMP‑relevant instruments and measurement devices are calibrated, maintained, and follow regulatory requirements.
They also manage sanitation efforts to maintain GMP standards and a clean, safe working environment.
This is an on‑site role 5 days per week based in Hamilton, ON.
Duties and Responsibilities:- Lead maintenance, reliability, and performance of GMP and non-GMP facility infrastructure, utilities, building systems, and critical equipment.
- Direct responsibility for GMP & non-GMP utilities (HVAC, compressed air, medical gas tank farms, RO/WFI/chilled water systems, boilers, steam systems, fire/sprinkler, fume hoods, BSC, humidifiers, UPS, emergency generators, door controls, exhaust fans and electrical systems, BMS/EMS).
- Ensure building infrastructure and essential service systems are operated and maintained to support safe, compliant, and uninterrupted manufacturing operations.
- Lead preventive, predictive, corrective, and emergency maintenance programs to improve equipment uptime and asset reliability.
- Ensure SOPs, PM plans, work instructions, and training programs are developed, routinely reviewed and revised as necessary.
- Oversee the site metrology and calibration program, ensuring GMP and non‑GMP instruments and measurement devices are calibrated, maintained, and compliant with regulatory requirements.
- Ensure work related to maintenance and calibration is documented, approved and controlled in QMS and CMMS systems (service reports, work orders, calibration certificates)
- Ensure compliance with cGMP, SHE, and regulatory standards, and support deviations, investigations, CAPAs, change controls, risk assessments, and quality systems.
- Support internal audits, customer audits, and regulatory inspections by maintaining inspection readiness, providing technical expertise and documentation, and ensuring timely resolution of audit observations.
- Manage contractors, service providers, and maintenance vendors for building infrastructure and essential service networks to ensure safe, compliant, and effective execution of work.
- Coordinate measurement and calibration vendors & contractors for GMP and non‑GMP areas
- Lead, develop, and mentor facilities maintenance, instrumentation, metrology, and sanitation personnel, encouraging a culture of safety, accountability, and ongoing improvement.
- Provide management and oversight for process controls, automation, and building management/monitoring Systems
- Lead the sanitation team and ensure cleaning and sanitation programs meet GMP,…
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