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Validation Engineer

Intellectt Inc3 days ago
Toronto, Ontario, Canada
Senior Level
CONTRACTOR

About the role

Job Title: Industrial Automation / CSV Engineer Location: Phase 1 – Toronto, Canada (15 Weeks) | Phase 2 – Mesa, AZ (8 Weeks) Duration: 6+ Months Contract (September 2026 – March 2027) Work Schedule: 90–100% Onsite Industry: Medical Device / Life Sciences

Overview We are seeking experienced Industrial Automation / CSV Engineers to support the commissioning, qualification, and validation of automated manufacturing and inspection equipment for a leading Medical Device client. The role involves supporting Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, commissioning, software verification & validation, and IQ/OQ activities while ensuring compliance with GMP and regulatory requirements.

Key Responsibilities Author, review, and execute FAT, SAT, IQ, OQ, TMV, and Gage R&R protocols. Support installation, commissioning, and qualification of automated assembly and inspection equipment. Perform PLC, HMI, SCADA, vision system, and database functional testing. Verify alarms, interlocks, safety functions, and software functionality. Execute software verification and validation activities, including unit, integration, feature, and user acceptance testing. Troubleshoot automation systems and coordinate issue resolution with equipment vendors. Document deviations, support change controls, and maintain commissioning documentation. Participate in punch-list resolution and support equipment turnover to manufacturing. Collaborate with Engineering, Quality, Validation, Manufacturing, and vendor teams throughout the project lifecycle.

Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related discipline. Minimum 6 years of experience with PLC/SCADA-controlled industrial automation equipment in regulated manufacturing environments. Hands-on experience authoring and executing FAT, SAT, IQ, OQ, and TMV protocols. Experience performing software verification and validation for automated manufacturing equipment. Strong knowledge of Rockwell Automation and FactoryTalk View. Experience working with databases and data integrity principles. Medical Device manufacturing experience is highly preferred.

Preferred Technical Skills PLC Programming & Troubleshooting HMI & SCADA Systems Vision Systems FactoryTalk View Rockwell Automation FAT / SAT IQ / OQ / TMV Software Validation (CSV/CSA) Gage R&R Equipment Commissioning Automated Manufacturing Equipment Database Validation Change Control Technical Documentation Regulatory Knowledge GMP Good Documentation Practices (GDP) FDA 21 CFR Part 11 EU Annex 11 GAMP 5 ALCOA+ Data Integrity Principles Equipment Lifecycle & Commissioning Documentation

About Intellectt Inc

Engineering Services
201-500

Welcome to Intellectt, where the convergence of emerging technologies, domain expertise and innovation drives excellence. Intellectt is a leading provider of Engineering, IT, and consulting services. Our dedication to customer success and our ability to scale on demand have propelled us to become one of the fastest-growing companies in the technology services segment in the US, over the last five years. Intellectt offers deep domain expertise in manufacturing, medical devices, healthcare, banking, financial services and other industries, alongside robust capabilities in emerging technologies like Artificial Intelligence (AI), NLP, Block Chain, Cloud and others. This unique combination enables our customers to navigate the complexities of today's technology and business landscape in order to achieve their goals.

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