Senior Validation Specialist

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases.

We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

About the Role

The Senior Validation Specialist supports compliance with Good Manufacturing Practices (GMP) in relation to validation and qualification activities. These activities are performed in support of the production of both clinical and commercial products, from the introduction of new programs to the routine manufacturing phase at AtomVie facilities.

What You Will Do

• Participates in the development and approval of User Requirement, Functional & Design Specifications documents.
• Develop risk assessments to determine validation scope and approach for new & existing AtomVie equipment, processes and computer systems.
• Provides guidance as it relates to the programs of validation and qualification activities.
• Authors, reviews, approves and executes validation protocols and reports.
• Supports periodic reviews of validated systems and equipment and develops mitigation strategies for any deficiencies identified.
• Ensures that GMP guidelines, company's policies and procedures are followed in relation to validation and qualification activities.
• Helps maintain the Company Validation Master Plan and ensures that it remains in compliance with regulatory requirements and company's policies and procedures.
• Creates and revises validation & qualification procedures to maintain compliance with current GMP guidelines, company's policies, and best practices.
• Reviews and approves records associated with the validation, qualification, and calibration programs (e.g., protocols, specifications, scripts, reports, risk assessments, certificates, non-conformances, change controls, etc.).
• Ensures quality management is informed of validation activities status and adherence to commitments.
• Coordinates activities with affected departments and project team members.
• Serves as the Quality Assurance representative on cross-functional teams to support transition of manufacturing processes from validation to routine production.
• Works closely with other departmental managers to ensure employees are working in compliance with internal policies and procedures, external client expectations, and GMPs.
• Communicates quality and compliance issues to all relevant stakeholders in a timely manner.
• Ensures AtomVie is inspection ready and is operating within a compliant quality environment.

What You Bring to the Role

• Excellent technical report writing skills, ability to understand and analyze technical systems.
• Knowledgeable in GxP, GDP, GAMP, 21CFR Part 11, and industry best practices.
• Attention to detail, highly organized, critical thinking, strong problem solving, interpersonal and verbal skills.
• Ability to develop and maintain relationships with internal and external business partners.
• Proficient in a variety of software applications (e.g., Microsoft Word, Excel, PowerPoint, Project, Visio, ETQ Reliance, Empower3, etc.).
• Knowledgeable of the processes and controls applied in the radiopharmaceutical industry.
• Ability to adjust work schedule based on business requirements.

Requirements

• Bachelor's degree in sciences, engineering, or equivalent preferred.
• 7+ years of direct experience of validation/qualification in the pharmaceutical manufacturing environment.
• Candidates with experience in new facility commissioning/qualification, computer validation, sterilization process validation and/or aseptic parenteral manufacturing preferred.

AtomVie Offers

• Group Health & Dental Benefits (from day 1)
• RRSP Matching Program
• Perkopolis
• Employee Assistance and Wellness Programs
• Parking Allowance

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.