Job Title

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor 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 RoleThe Validation Technical supports compliance with Good Manufacturing Practices (GMP) in relation to validation, qualification and maintenance 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 DoExecute and review validation and qualification protocols.Author validation and qualification protocols and reports.Review of executed maintenance and calibration records.Facilitate client review and approval of AtomVie documentation.Ensures that GMP guidelines, companys policies and procedures are followed in relation to validation and qualification activities.Ensures quality management is informed of validation activities status and adherence to commitments.Participate in quality investigations, non-conformances documentation and continuous improvement initiatives.Completes all other duties as assigned. Coordinates activities with affected departments and project team members.Establishes strong relationships inter- and intra-departmentally.Works closely with other departmental managers to ensure employees are working in compliance with internal policies and procedures, external client expectations, and GMPs.Ensures AtomVie is inspection ready and is operating within a compliant quality environment.Ensures compliance with Health and Safety, engaging all associates to comply with the policies, procedures and regulations applicable to their job.What You Bring to the Role2 years experience in the pharma/biotech manufacturing field, and quality environments/organizations.2 years of direct experience in validation/qualification.Excellent technical report writing skills, ability to understand and analyze technical systems.Exposure to computer systems validation preferably in the pharmaceutical industry in the areas of Quality, IT, and Manufacturing.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, etc.).Knowledgeable of the processes and controls applied in the radiopharmaceutical industry.Ability to adjust work schedule based on business requirements. RequirementsBachelors degree in sciences, engineering, or equivalent preferred.AtomVie OffersGroup Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking AllowanceAtomVie 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.