Role: Industrial Automation & CSV Validation Engineer

Location: Cambridge, Ontario, Canada | Onsite

Position Overview

We are seeking experienced Industrial Automation & CSV Validation Engineers to support the validation, commissioning, and qualification of PLC- and SCADA-controlled automated assembly equipment within a regulated manufacturing environment.

The ideal candidates will have strong hands-on experience with industrial automation, computerized system validation (CSV), PLC/SCADA testing, and equipment qualification, preferably within the medical device, pharmaceutical, biotechnology, or other regulated industries.

Candidates must be local to Cambridge, Ontario, or willing to relocate for the duration of the project. Travel, lodging, and relocation expenses are not included.

Key Responsibilities

- Author, review, and execute FAT, SAT, IQ, OQ, and Test Method Validation protocols.
- Perform validation testing for PLC- and SCADA-controlled automated assembly and manufacturing equipment.
- Execute software verification and validation activities throughout the system lifecycle.
- Test PLC logic, interlocks, alarms, sequences, recipes, equipment functions, and HMI/operator interfaces.
- Perform functional, unit, integration, regression, and User Acceptance Testing (UAT).
- Verify automation systems against approved User Requirements Specifications (URS), functional requirements, and design specifications.
- Develop test scripts, acceptance criteria, requirements traceability matrices, validation reports, and supporting documentation.
- Review PLC, SCADA, and HMI configurations from a validation and compliance perspective.




- Support Rockwell Automation platforms and FactoryTalk View applications.
- Verify communication between PLCs, HMIs, SCADA systems, equipment controllers, and databases.
- Evaluate electronic records, system access, audit trails, data storage/retrieval, and data-integrity controls.
- Document test results, deviations, discrepancies, defects, and corrective actions.
- Troubleshoot automation, software, communication, and system-integration issues identified during testing.
- Support deviation investigations, root-cause analysis, impact assessments, and resolution of validation exceptions.
- Collaborate with Automation, Engineering, Manufacturing, Quality, IT, Validation, and equipment vendors.
- Support equipment commissioning, startup, qualification, and production handover.
- Maintain validation documentation in accordance with approved procedures and applicable regulatory requirements.

Required Qualifications

- 6+ years of experience with PLC- and SCADA-controlled industrial automation or automated assembly equipment.
- Experience working in a regulated manufacturing setting, preferably medical device, pharmaceutical, or biotechnology.
- Strong experience authoring and executing FAT, SAT, IQ, and OQ protocols.




- Hands-on experience developing or executing Test Method Validation protocols.
- Strong understanding of Computerized System Validation (CSV) and software verification/validation lifecycles.
- Experience performing logic, alarm, feature, unit, integration, regression, and UAT testing.
- Strong experience with Rockwell Automation platforms.
- Hands-on experience with FactoryTalk View.
- Strong understanding of PLC programming, control-system architecture, industrial networks, and automated equipment integration.
- Experience with databases, electronic records, and data-integrity principles.
- Strong technical writing, validation documentation, troubleshooting, and communication skills.
- Ability to work independently in a fast-paced, cross-functional project environment.
- Ability to work onsite in Cambridge, Ontario for the duration of the assignment.

Preferred Qualifications

- Experience validating automated medical device assembly or manufacturing equipment.
- Experience with Allen-Bradley ControlLogix or CompactLogix PLCs.
- Experience with Studio 5000 and FactoryTalk View SE/ME.
- Experience with Rockwell industrial communication networks.
- Familiarity with 21 CFR Part 11, GAMP 5, ISO 13485, FDA Quality System requirements, and data-integrity principles.
- Experience supporting equipment commissioning, startup, and qualification projects.
- Experience working directly with equipment vendors during FAT and SAT.
- Familiarity with requirements traceability, risk assessments, validation deviations, and final validation summary reports.

📌 Industrial Automation & CSV Validation Engineer (Ontario)
🏢 United Pharma Technologies
📍 Ontario