Job Title: Industrial Automation / CSV Engineer Location: Canada | Onsite

Position Overview We are seeking an experienced Industrial Automation / Computer System Validation (CSV) Engineer to support the commissioning, qualification, and validation of automated manufacturing and inspection systems within a regulated Medical Device environment. This role will be responsible for validating automation hardware and software, supporting equipment startup, and ensuring compliance with FDA, GMP, and GAMP 5 requirements throughout the equipment lifecycle.

Key Responsibilities Develop, review, and execute validation documentation including FAT, SAT, IQ, OQ, TMV, Gage R&R, and validation summary reports. Support installation, commissioning, startup, and qualification of automated manufacturing and inspection equipment. Perform functional testing of PLC, HMI, SCADA, vision systems, databases, and automation software. Verify alarms, interlocks, safety features, and system functionality to ensure operational readiness. Execute Computer System Validation (CSV) activities, including software verification, unit testing, integration testing, functional testing, and User Acceptance Testing (UAT). Identify, troubleshoot, and resolve automation and validation issues in collaboration with equipment vendors and cross-functional teams. Document deviations, manage change controls, and maintain complete commissioning and validation documentation. Support punch-list resolution, equipment turnover, and transition into manufacturing operations. Partner with Engineering, Manufacturing, Quality, Validation, and external vendors throughout project execution. Ensure all validation activities comply with regulatory requirements and internal quality standards.

Required Qualifications Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical field. 6+ years of experience supporting industrial automation, commissioning, and validation within a regulated manufacturing environment. Hands-on experience authoring and executing FAT, SAT, IQ, OQ, TMV, and equipment qualification protocols. Experience performing Computer System Validation (CSV) or Computer Software Assurance (CSA) for automated manufacturing equipment. Strong working knowledge of Rockwell Automation PLCs and FactoryTalk View. Experience validating databases and applying data integrity principles. Excellent troubleshooting, documentation, and cross-functional communication skills. Prior experience in Medical Device manufacturing is highly preferred.