Process 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 Process Validation Specialist oversees validation activities for both investigational and commercial products at AtomVie. This position will act as an interface between quality, radiopharmaceutical development, regulatory and production to ensure that all quality activities are conducted in compliance with relevant internal procedures, client requirements and the applicable regulations. This posting is for an existing vacancy to support the expansion of the company. What You Will Do

Develop and execute qualification and validation protocols for the introduction and maintenance of investigational and commercial products and processes at AtomVie Global Radiopharma. Preparation and execution of process validation / qualification protocols and reports for investigational and commercial products and processes, including:

Airflow visualization (smoke study) Stability protocols Validation and qualification related non-conformances, change controls and CAPAs.

Support introduction and maintenance of client documents, such as:

Review and approval of Master Batch Records Creation and maintenance of label specification / templates Tracking and trending of critical process parameters and critical quality attributes.

Oversee assigned projects and when required execute project deliverables to ensure that high quality standards are met within the projected timelines and project outcomes are compliant with internal/external requirements and GMP regulations. Contribute to the development of tasks and timelines as they pertain to quality assurance requirements for assigned projects, working with members of the QA team to ensure deliverables are met according to plan. Participate in regulatory and client GMP inspections, as needed, and contribute to formal audit responses and CAPAs. What You Bring to the Role

Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of the regulations as they pertain to sterile products Proficiency in the English language both written and oral, and excellent communication skills; detail-oriented Ability to work independently and possess excellent organizational skills Strong client-facing and teamwork skills Requirements

Post-Secondary Education in Engineering, Chemistry, Microbiology or a related field 5 to 7 years of relevant experience Experience working in a GMP environment is required Experience preparing / executing validation and qualification protocols is required, with Process Validation experience preferred. Training and experience in quality systems, quality audits, good documentation practices, change controls, CAPAs and review of quality records. Compensation

Annual salary starts at $70k. Group Health & Dental Benefits (from day 1) RRSP Matching Program Employee Assistance and Wellness Programs AtomVie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process. We are 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.

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