CQV Specialist I (Lab)

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

Benefits offered by this job

Group Health & Dental

RRSP Matching

Employee Wellness Programs

Job summary

AtomVie Global Radiopharma Inc. is seeking a CQV Specialist (Lab) to support calibration, qualification, and documentation in a GMP environment. You will coordinate with third-party contractors and contribute to continuous improvement within Engineering.

This role supports expansion and requires collaboration across multiple sites, with emphasis on laboratory equipment and software validation. Excellent technical writing and GMP knowledge are essential.

Qualifications

• College diploma in a technical field (Metrology, Pharmaceutical Sciences) or equivalent experience.
• Minimum 2–5 years hands-on GMP pharmaceutical lab experience (Metrology role preferred).
• Ability to lift 50 lbs, crawl, stoop, crouch, and kneel in small spaces.
• Excellent verbal and written communication and documentation skills.

Responsibilities

• Manage and execute vendor and internal calibration and preventive maintenance programs, including review/approval of service records and reports to ensure completeness and accuracy.
• Perform equipment qualification and validation activities across AtomVie, e.g., HPLC qualifications and GC equipment qualification and balance verification.
• Create/Develop the lab instrument SOPs and maintenance programs in CMMS.
• Lead/Support development and execution of qualification documentation for laboratory equipment and software validation.
• Collaborate across teams and locations to implement calibration programs in accordance with cGMP and Validation Plan.

Skills

Health Canada regulations

FDA regulations

Empower CDS

Waters HPLC

Education

College diploma in Metrology/Pharmaceutical Sciences

Tools

CMMS

Job description

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.

AboutTheRole

Reporting to the Engineering Manager as a CQV Specialist (Lab),assisttheEngineeringdepartmentfocusedonlaboratoryequipmentqualifications,calibrations,recertifications,anddocumentationexecutionincompliancewithGMPpractices.Thisrolewillalsocoordinatethird-partycontractorsandcontributetothecontinuousimprovementoftheengineeringdepartment..

This posting is for an existing vacancy to support the expansion of the company.

WhatYouWillDo

• Manageandexecutevendorandinternalcalibration&preventivemaintenanceprograms,includingthereviewandapprovalofservicerecordsandreports(e.g.,calibrationcertificates,completedprotocols,workorders,andvendorreports)toensurecompletenessandaccuracy
• PerformequipmentqualificationandvalidationactivitiesacrossAtomVie.SuchasexecutingHPLCannualqualifications,GasChromatographyequipmentqualificationandbalancesperformanceverificationandannualcalibrationetc.
• Create/DevelopthelabinstrumentoperationalSOPandmaintenanceprogramsinCMMS.
• Lead/Supportthedevelopmentandexecutionofallqualificationdocumentationrelatedtolaboratoryequipmentandsoftwarevalidation.
• CollaborateacrossteamsandlocationstoensurecalibrationprogramsareimplementedandmaintainedinaccordancewithcGMPsandtheValidationPlan.
• InvestigateandtroubleshootproblemsrelatingtoanyCQVtasks.Providetechnicalassistanceduringinvestigationsofequipmentandvalidationissues,aidintheresolutionofqualification/validationdeviationsandprotocoldiscrepancies.
• Lead/Supportnon-conformancesrelatedtodeviationsoccurringwhenequipmentfailstomeetacceptancecriteria
• AssistorleadthetroubleshootingandrepairofproductionandQCrelatedequipmentasneeded
• Co-ordinatewiththedirectsupervisorandtechnicianstoensuremanagementandQAareinformedofcompliancestatusandadherencetocommitments.
• Lead and author nonconformance reports, change controls, and CAPAs, ensuring follow-through to completion within the proposed timeline.

WhatYouBringtotheRole

• SoundknowledgeofauthorityregulationslikeHealthCanadaandFDAetc.
• ExcellentknowledgeofoperatingEmpowerCDSandoperatingandtroubleshootingonWatersHPLCsystems.
• Demonstratedabilitytosuccessfullyprioritize,managetimewell,multitask,andtroubleshoot.
• Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.

Requirements

• AminimumofaCollegeDiplomainatechnicalfield(Metrology,PharmaceuticalSciencesetc.,)orrelevantexperience.
• Minimumof2-5yearshandsonworkingexperienceinGMPPharmaceuticallabsettingpreferablytheMetrologyrole.
• Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.

Compensation

Annualsalarystartsat$64k.Compensationisbasedonrelevantindustryexperience,academiccredentials,andqualifications.

• GroupHealth&DentalBenefits(fromday1)
• RRSPMatchingProgram
• EmployeeAssistanceandWellnessPrograms

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.