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Job Title


Qualification Engineer


Company : Tekgence Inc


Location : Mississauga, Ontario


Created : 2025-12-15


Job Type : Full Time


Job Description

Job Opportunity: Qualification Specialist Equipment Integration (Contract)We are seeking an experienced Qualification Specialist to join our Equipment Integration team, playing a critical role in transferring existing Lab Equipment from our Spark Network to the Roche Connect Network (RCN).If you are a seasoned Validation professional ready to lead compliance for digital solutions and infrastructure in a fast-paced GMP environment, this is for you!Key Requirements & Experience Needed (Must-Haves):9+ years in Computer Systems Validation (CSV) or Equipment Qualification within the Pharmaceutical/Life Sciences industry (GMP/GxP).Proven experience in developing a Validation Master Plan (VMP) from scratch.Strong practical experience with the PI Historian System.Expertise in qualifying integrated hardware, software, and automation applications (IQ/OQ/PQ) against GAMP 5 and 21 CFR Part 11.Background in managing infrastructure through multiple product releases and overseeing end-to-end data migration/configuration.