Manager, Manufacturing Technical Services
About The Position
Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radioconjugates that deliver powerful alpha-emitting payloads directly to tumors. Our pipeline spans multiple first-in-class programs—backed by a GMP‑compliant, state-of-the-art radiopharmaceutical facility in Hamilton, we’re turning cutting‑edge science into real‑world impact for patients. Join us at the forefront of radiopharma innovation and be part of turning breakthrough science into meaningful outcomes for patients—come build what’s next with us! The role: Reporting to the Associate Director, Process Engineering, this role is critical for ensuring up-time of process equipment and implementing Good Engineering Practices within our Hamilton, Ontario clinical radiopharmaceutical manufacturing facility, adhering to strict GxP and CNSC licensing requirements. This is a hands-on role, requiring familiarity with a variety of electrical and mechanical tools.
Requirements
- Degree or higher in Engineering, or a related field preferred.
- 5+ years of relevant experience, within a biotech, pharmaceutical, or radiopharmaceutical setting.
- Technical, hands-on experience with electro-mechanical equipment.
- Maintenance leadership on sophisticated, cGMP-related infrastructure with 24/7 reliability expectations.
- Proven safety, cGxP compliance, and quality systems ownership.
- Demonstrably detail oriented in documentation and work planning
- Track record in investigations (RCA/CAPA) and team development.
Nice To Haves
- Handling of open sources of radioactive materials
- Experience working within nuclear regulated facilities
- Light machining (milling, drilling) and workshop skills
Responsibilities
- Lead and own the maintenance of process equipment used in the production of radioactive pharmaceuticals.
- Perform first line maintenance and troubleshooting on radiopharmaceutical process equipment such as automated synthesis units (Trasis), Hot Cells (TEMA and Comecer), telemanipulators (Wälischmiller) and Isolators (Esco)
- Coach technicians, engineers, apprentices and contractors; build capability and strong cross-functional ties.
- Work within a Quality Management System to develop SOPs, define corrective actions, manage changes and address deviations.
- Work within a radiation safety program to ensure that radiation doses to personnel are kept ALARA.
- Work closely with Site Operations team to plan outages on building utilities (HVAC, electrical, gas supplies)
- Work closely with Validation team to qualify new equipment and prepare existing equipment for calibration.
- Development and execution of IQOQ on new equipment
- Set spare parts stocking and reordering strategies to protect reliability.
- Contribute to site planning, procedures, budgets, schedules, and performance metrics, brief senior stakeholders.
Benefits
- Annual Variable Pay Bonus/Short Term Incentive opportunity
- eligibility to participate in our equity-based long-term incentive program (if applicable to role)
- competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- annual Personal Days
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
