Validation Associate

Description:

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.

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.

Qualifications:

• 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.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 11 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

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 AZCHumanResources@astrazeneca.com

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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.