GMP CQV Specialist: Lab Qualification & Validation Lead

AtomVie Global Radiopharma Inc.; Hamilton; On-site; CAD 58,000 - 70,000; Full time

Benefits offered by this job

Group Health & Dental Benefits (from 1

RRSP Matching Program

Employee Assistance and Wellness

Job summary

AtomVie Global Radiopharma Inc. is seeking a CQV Specialist to support laboratory equipment qualifications, calibrations, recertifications and validation documentation in a GMP setting.

The role includes coordinating third-party contractors and driving continuous improvement across the engineering department. You will manage calibration programs, perform qualification activities such as HPLC and GC validations, and develop SOPs in CMMS.

Qualifications

• Knowledge of Health Canada and FDA regulations.
• Experience operating Empower CDS and Waters HPLC systems.
• Ability to prioritize, multitask, and troubleshoot in GMP labs.
• Excellent written and verbal communication for technical reports.

Responsibilities

• Manage calibration & preventive maintenance programs; review service records.
• Execute equipment qualification/validation activities (HPLC qualification, GC qualification, balances calibration).
• Develop lab SOPs and CMMS maintenance programs.
• Lead qualification documentation and deviation investigations; CAPAs.
• Coordinate with QA and technicians to maintain compliance status.

Skills

Regulatory knowledge (Health Canada, U

Empower CDS

HPLC operation

Troubleshooting

Communication

Education

College Diploma in Metrology/Pharmaceutical Sciences

Tools

Waters HPLC

Job description

AtomVie Global Radiopharma Inc. is seeking a CQV Specialist to support laboratory equipment qualifications, calibrations, recertifications and validation documentation in a GMP setting.

The role includes coordinating third-party contractors and driving continuous improvement across the engineering department. You will manage calibration programs, perform qualification activities such as HPLC and GC validations, and develop SOPs in CMMS.