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

Reporting to the Engineering Manager - Facilities & Maintenance, the CQV Technician will assist the Engineering department with tasks such as equipment calibrations, recertifications, and documentation execution in compliance with GMP practices. This role will also coordinate third-party contractors and contribute to the continuous improvement of the engineering department. The primary objective is to support the execution of all CQV activities in alignment with standards and AtomVie's requirements

What You Will Do

• Manage and execute vendor and internal calibration programs, including the review and approval of service records and reports (e.g., calibration certificates, completed protocols, work orders, and vendor reports) to ensure completeness and accuracy
• Collaborate across teams and locations to ensure calibration programs are implemented and maintained in accordance with cGMPs and the Validation Plan
• Perform equipment re-qualification and re-validation activities across AtomVie. Such as executing smoke studies for Grade A Hot cells, BSCs, Isolators and temperature / humidity mapping for Controlled Temperature Units, material storage areas.
• Co-ordinate with the production and other teams to ensure that calibration and re-qualification activities do not impact on their schedules.
• Support the development and execution of all commissioning and qualification documentation related to thermal studies, validation studies for equipment, facilities, development studies and software validation.
• Investigate and troubleshoot problems relating to any CQV tasks. Provide technical assistance during investigations of equipment and validation issues, aid in the resolution of validation deviations and protocol discrepancies.
• Address non-conformances related to deviations occurring when equipment fails to meet acceptance criteria
• Demonstrate safety knowledge, awareness and compliance with all safety and other job-related policies and procedures.
• Assist or lead the troubleshooting and repair of production and QC related equipment as needed
• Co-ordinate with the direct supervisor and technicians to ensure management and QA are informed of compliance status and adherence to commitments.
• Participate in compulsory training as deemed necessary for the role.
• Complete all other duties as required.

What You Bring to the Role

• Passion for driving continuous improvements in processes, efficiency, and overall performance through innovative solutions and data-driven strategies
• Solid understanding of cGMP validation requirements / guidelines and current industry practice.
• Thrives in a fast-paced setting
• Ability to work independently and possess excellent organizational skills.
• Highly motivated with strong attention to detail

Requirements

• A minimum of a College Diploma/degree in a technical field or related (Engineering, Metrology, Pharmaceutical Sciences etc.,) or relevant experience.
• Minimum Two (2) to five (5) years of applied technical experience within the CQV space of the pharmaceutical, health sciences, or biotech industries, managing equipment with direct impact to product testing and quality.
• Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot.
• Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.
• Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.

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.