CQV Specialist I

AtomVie Global Radiopharma•Hamilton, ON

19h•CA$0 - CA$64,000•Onsite

About The Position

The CQV Specialist (Manufacturing Systems) will assist the Engineering department focusing on manufacturing equipment qualifications, 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 CQV activities in alignment with standards and AtomVie’s requirements.

Requirements

A minimum of a College Diploma in a technical field (Pharmaceutical Sciences, Mechanical, Mechatronics etc.,) or relevant experience.
Minimum Two (2) to five (5) years hands on working experience in Pharma or food manufacturing facility in a technical capacity.
Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.

Nice To Haves

Sound knowledge of authority regulations like Health Canada and FDA etc.
knowledge of Isolators / RABS is an added Asset.
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.

Responsibilities

Perform equipment qualification and validation activities across AtomVie. Such as executing Cleanrooms, Isolators, Hot cells, RABS, Biological safety cabinet, fume hoods performance verification and qualification etc.
Manage and execute vendor and internal qualification and certification programs, including the review and approval of qualification protocols and reports to ensure completeness and accuracy
Collaborate across teams and locations to ensure qualification programs are implemented and maintained in accordance with cGMPs and the Validation Plan
Create/Develop the equipment operating SOPs and maintenance programs in CMMS.
Co-ordinate with the production teams to ensure that re-qualification activities do not impact on their schedules.
Lead/Support the development of (IQ/OQ/PQ) qualification documents as required and execution of all qualification documentation related to manufacturing equipment 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 qualification/validation deviations and protocol discrepancies.
Lead/Support 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.
Participating in compulsory training is deemed necessary for the role.
Ensure compliance with Health, Safety and Environment protection rules, with engagement of all associates to apply the policies, procedures and regulations applicable to their work.
Demonstrate safety knowledge, awareness and compliance with all safety and other job-related policies and procedures
Lead and author nonconformance reports, change controls, and CAPAs, ensuring follow-through to completion within the proposed timeline.