Validation Associate

AstraZeneca • Hamilton, ON

1d • CA$69,312 - CA$90,972 • Onsite

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, brand new radiopharmaceutical facility in Hamilton, we’re turning groundbreaking 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: The Validation Associate, under the guidance of the Senior Validation Lead, will participate in activities regarding facility qualification, equipment qualification, cleanroom and clean air equipment qualification, and computer systems validation. This role ensures compliance to applicable regulatory requirements and guidelines, as well as internal Fusion SOPs, while delivering to the objectives of applicable programs and strategic objectives, in alignment with both the Quality, Facilities Management and Operations Departments. This role will report to the head of QA – Validation.

Requirements

• Bachelor's degree in science or engineering with 2-3 years of relevant experience in a regulated industry.
• Must be on-site (Hamilton, ON) for support of ongoing activities.
• Familiarity with validation and qualification requirements for sterile manufacturing in pharmaceutical environment.
• Experience in the generation and/or execution of qualification protocols and validation plans.
• Familiar with applicable regulatory guidance on validation, qualification, and sterile drug manufacturing.
• Excellent interpersonal skills, including team-oriented approach with ability to partner with others in fast paced, rapidly changing environment.
• Must possess excellent written, organizational and communication skills.

Responsibilities

• Participate in the development, execution and review of Computer Systems Validations (CSV)
• Participate in the development, execution, and review of Installation, Operational, Performance Qualification (I/O/PQ) protocols for Computer Systems (CSV), Facilities, Lab and Production Equipment, Cleanrooms.
• Monitor and maintain Calibration and Preventative Maintenance schedule.
• Coordinate with the Validation Lead, and other stakeholders to ensure validation status is maintained. This includes assessing changes to the validation status, periodic review, data integrity and risk assessments for all GxP Equipment.
• Help update and maintain the Validation Master Plan, and validation plans for individual projects.
• Effectively communicate on a timely basis with management and other departments to ensure clear understanding and acknowledgement of project status, risks, actions and outcomes, and to ensure roadblocks are identified early and resources are coordinated to ensure timelines are met.
• Ensure knowledge and adherence to regulatory guidelines and updates.

Benefits

• Annual base salary for this position ranges from 69,312.00 to 90,972.00.
• 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
• Contract Benefits Program (for Fixed Term Contract/Temporary positions excluding students)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level