Validation Associate

Responsibilities

• Participate in the development, execution, and review of Computer Systems Validations (CSV)
• Develop, execute, and review Installation, Operational, and Performance Qualification (I/O/PQ) protocols for computer systems, facilities, lab/production equipment, and cleanrooms
• Monitor and maintain calibration and preventative maintenance schedules
• Coordinate with the Validation Lead to maintain validation status, including assessing changes, periodic reviews, data integrity, and risk assessments for GxP equipment
• Assist in updating and maintaining the Validation Master Plan and individual project validation plans
• Communicate project status, risks, and outcomes to management and cross-functional departments to ensure timelines are met
• Ensure adherence to all applicable regulatory guidelines and updates

Requirements

• Bachelor's degree in science or engineering
• 2-3 years of relevant experience in a regulated industry
• Must be able to work onsite in Hamilton, Ontario
• Familiarity with validation and qualification requirements for sterile manufacturing in a pharmaceutical environment
• Experience generating or executing qualification protocols and validation plans
• Knowledge of applicable regulatory guidance regarding validation, qualification, and sterile drug manufacturing
• Excellent written, organizational, and interpersonal communication skills

About the Company

Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next-generation radioconjugates. Operating from a GMP-compliant radiopharmaceutical facility in Hamilton, we turn groundbreaking science into meaningful outcomes for patients.