Manager, Facilities Maintenance

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radioconjugates (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 radioconjugate 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 (TSSA/ESA etc).
• 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, safety, and environmental requirements.
• Partner with Manufacturing, Engineering, Quality, Laboratory, IT, SHE, and external collaborators to support operational readiness and business objectives.
• Support capital projects, equipment installations, facility upgrades, commissioning, qualification, validation, and startup activities.
• Support commissioning, qualification, requalification, and validation activities for facilities, utilities, and equipment.
• Develop and handle departmental budgets, maintenance targets, energy and sustainability initiatives, and ongoing improvement programs to enhance reliability, compliance, and cost effectiveness.
• Work closely with multi-functional teams and cultivate strong relationships with staff, collaborators, landlord, and service providers.
• Coach, mentor and provide direct and indirect leadership to mechanics, electrical/instrumentation/metrology technicians, sanitation and automated systems technicians.
• Maintain integrity of system architecture documentation, P&IDs, device mapping, and database backups.
• Drive the transition from reactive, tactical maintenance execution to a proactive, reliability- and risk-based facilities and engineering operating model
• Familiarity with AI tools, including Microsoft Copilot, and a commitment to continuous improvement and process optimization.
• Monitor critical systems and provide 24-hour on-call support as required
• Other duties as assigned.

Qualifications:

• Bachelor’s degree/diploma in engineering (Mechanical, Electrical, Chemical, Industrial, or related discipline), or a related technical field required.
• Minimum 7–10 years of progressive experience in facilities maintenance, utilities, engineering, or technical operations within a GMP-regulated pharmaceutical, biotechnology, radiopharmaceutical, or life sciences manufacturing environment.
• Minimum 3–5 years of leadership experience managing maintenance, metrology, utilities, and/or facilities teams.
• Professional Engineering (P.Eng.), Certified Maintenance & Reliability Professional (CMRP), Facilities Management Professional (FMP), or equivalent certification is considered an asset.
• Knowledge of Lean management principles and waste-reduction strategies. Lean Six Sigma certification is a strong asset
• Strong knowledge of cGMP regulations, facility and utility systems, maintenance best practices, and regulatory compliance requirements.
• Experience with computerized maintenance management systems (CMMS), calibration management systems, and building automation/control systems.
• Demonstrated experience supporting audits, inspections, deviations, CAPAs, change controls, and qualification activities in a regulated environment.
• Strong leadership, project management, contractor management, and continuous improvement skills.
• Experience supporting Health Canada, FDA, and other regulatory inspections.
• Ability to read and interpret architectural, electrical and mechanical drawings.
• Excellent interpersonal, verbal, and written communication skills.
• Experience in personal computers with preference given to a Windows 365 operating system, Microsoft Word, Excel, PowerPoint, Microsoft Teams, and using SAP.

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Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected]

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Annual base salary for this position ranges from 128,871.20 to 169,143.45.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.