Validation Associate

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 connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.

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 Senior Validation Lead.

This position will be based onsite at our Hamilton, Ontario location.

Responsibilities

• Participate in the development, execution, and review of Installation, Operational, Performance Qualification (I/O/PQ) protocols for Facility, Equipment, Cleanroom, Clean Air Equipment, and Computer Systems (CSV).
• 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 3-5 years of 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.
  
  

Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes, if contacted for an interview, please advise Human Resources if you require accommodation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran