Senior Validation Specialist

at  Fusion Pharmaceuticals US Inc

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals 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; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.
The Role: The Senior Validation Specialist will lead projects which include activities such as facility qualification, equipment qualification, cleanroom and clean air equipment qualification, and computer validation. This role ensures compliance to applicable regulatory requirements and guidelines, 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 directly to the Director, Site Quality.

Responsibilities:

• In collaboration with Quality, Facilities, and Operations, plan, coordinate and drive assigned projects which include qualification activities related to the introduction, or changes to facilities, equipment, cleanrooms, clean air equipment, and computer systems. Ensure roadblocks are identified early and resources are coordinated to ensure timelines are met.
• Work with Facilities, QA and Operations and participate in the evaluation and risk assessment of data in order to: ensure all introductions and changes are appropriately documented demonstrating proper design, qualification, operation and maintenance.
• Develop and execute Installation, Operational, Performance Qualification protocols for Facility, Equipment, Cleanroom, Clean Air Equipment, and Computer systems.
• Develop and maintain Validation Master plans and applicable project specific validation plans.
• Assess changes to ensure validation status is maintained; and ensure introduction and changes to facilities, equipment, and computer systems meet their intended purposes.
• Conduct periodic review of facility cleanroom, clean air equipment, and manufacturing equipment.
• Monitor and maintain, Calibration and Preventative Maintenance schedule.
• Perform data integrity assessments for GxP equipment.
• Represent department on technical basis for assigned 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.
• Keep updated on regulatory guidelines.

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.
• In-depth knowledge of validation and qualification requirements for sterile manufacturing in pharmaceutical environment.
• Significant experience in the generation and 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.

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.

• In collaboration with Quality, Facilities, and Operations, plan, coordinate and drive assigned projects which include qualification activities related to the introduction, or changes to facilities, equipment, cleanrooms, clean air equipment, and computer systems. Ensure roadblocks are identified early and resources are coordinated to ensure timelines are met.
• Work with Facilities, QA and Operations and participate in the evaluation and risk assessment of data in order to: ensure all introductions and changes are appropriately documented demonstrating proper design, qualification, operation and maintenance.
• Develop and execute Installation, Operational, Performance Qualification protocols for Facility, Equipment, Cleanroom, Clean Air Equipment, and Computer systems.
• Develop and maintain Validation Master plans and applicable project specific validation plans.
• Assess changes to ensure validation status is maintained; and ensure introduction and changes to facilities, equipment, and computer systems meet their intended purposes.
• Conduct periodic review of facility cleanroom, clean air equipment, and manufacturing equipment.
• Monitor and maintain, Calibration and Preventative Maintenance schedule.
• Perform data integrity assessments for GxP equipment.
• Represent department on technical basis for assigned 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.
• Keep updated on regulatory guidelines