Industrial Automation and CSV Engineer

United Pharma; Cambridge; On-site; CAD 90,000 - 130,000; Full time

Job summary

United Pharma in Cambridge, Ontario seeks Senior Automation Validation Engineers to support automated medical-device assembly equipment validation and testing. The role emphasizes hands-on FAT/SAT/IQ/OQ/TMV activities, data integrity, and regulatory compliance within a modern manufacturing environment.

You will validate PLC/SCADA-controlled systems, collaborate across engineering, quality, and production teams, and contribute to successful protocol closeouts during the project lifecycle.

Qualifications

• Minimum of six years of experience with PLC- and SCADA-controlled automation or assembly equipment.
• Experience in a regulated manufacturing environment.
• Demonstrated expertise authoring and executing FAT, SAT, IQ, OQ, and TMV protocols.
• Strong understanding of the software verification and validation lifecycle.
• Advanced knowledge of PLC programming concepts and industrial automation architecture.
• Hands-on experience with the Rockwell Automation suite and FactoryTalk View.
• Experience testing equipment alarms, error codes, interlocks, system messages, and abnormal operating conditions.
• Working knowledge of electrical panels, controls, sensors, actuators, vision systems, and robotic machinery.
• Strong technical writing, troubleshooting, and cross-functional communication skills.

Responsibilities

• Author, review, and execute FAT, SAT, IQ, OQ, and Test Method Validation protocols.
• Plan and perform software verification and validation activities throughout the system lifecycle.
• Test PLC logic, equipment sequences, interlocks, alarms, error codes, system messages, and recovery conditions.
• Execute feature, unit, integration, functional, and User Acceptance Testing.
• Challenge sensors, actuators, electrical controls, safety devices, vision systems, and robotic equipment.
• Verify device assembly processes and equipment-based functional testing.
• Confirm part traceability, electronic records, database transactions, and system data flows.
• Assess data integrity controls in accordance with regulated-industry expectations.
• Review PLC programs, SCADA configurations, automation architecture, control narratives, and electrical documentation.
• Document test results, discrepancies, objective evidence, and deviations with a high level of accuracy.
• Collaborate with equipment suppliers, controls engineers, quality, manufacturing, and project stakeholders.
• Support troubleshooting, deviation resolution, corrective actions, and protocol closeout.

Skills

PLC programming

SCADA testing

Automation architecture

Data integrity

Regulated manufacturing

Technical writing

Cross-functional communication

Tools

Rockwell Automation

FactoryTalk View

Ignition SCADA

Job description

We are seeking experienced Senior Automation Validation Engineers to support our project involving automated and robotic medical-device assembly equipment.

The successful candidates will provide hands-on validation and testing support for PLC and SCADA controlled manufacturing systems. This role requires strong knowledge of industrial controls, automation architecture, equipment functionality, computerized system validation, data integrity, and regulated manufacturing practices.

Candidates must be local to the Cambridge, Ontario area or willing to temporarily relocate for the duration of the assignment. Routine travel expenses are not anticipated.

Key Responsibilities

• Author, review, and execute FAT, SAT, IQ, OQ, and Test Method Validation protocols.
• Plan and perform software verification and validation activities throughout the system lifecycle.
• Test PLC logic, equipment sequences, interlocks, alarms, error codes, system messages, and recovery conditions.
• Execute feature, unit, integration, functional, and User Acceptance Testing.
• Challenge sensors, actuators, electrical controls, safety devices, vision systems, and robotic equipment.
• Verify device assembly processes and equipment-based functional testing.
• Confirm part traceability, electronic records, database transactions, and system data flows.
• Assess data integrity controls in accordance with regulated-industry expectations.
• Review PLC programs, SCADA configurations, automation architecture, control narratives, and electrical documentation.
• Document test results, discrepancies, objective evidence, and deviations with a high level of accuracy.
• Collaborate and establish excellent rapport and communication with equipment suppliers, controls engineers, quality, manufacturing, and project stakeholders.
• Support troubleshooting, deviation resolution, corrective actions, and protocol closeout.

Required Qualifications

• Minimum of six years of experience working with PLC- and SCADA-controlled industrial automation or assembly equipment.
• Experience in a regulated manufacturing environment.
• Demonstrated expertise authoring and executing FAT, SAT, IQ, OQ, and TMV protocols.
• Strong understanding of the software verification and validation lifecycle.
• Advanced knowledge of PLC programming concepts and industrial automation architecture.
• Hands-on experience with the Rockwell Automation suite and FactoryTalk View.
• Experience testing equipment alarms, error codes, interlocks, system messages, and abnormal operating conditions.
• Working knowledge of electrical panels, controls, sensors, actuators, vision systems, and robotic machinery.
• Experience with databases, electronic records, part-traceability systems, and data-integrity principles.
• Ability to interpret PLC logic, electrical drawings, functional specifications, and equipment design documentation.
• Strong technical writing, troubleshooting, and cross-functional communication skills.

Strongly Preferred

• Medical-device assembly or manufacturing experience.
• Experience validating automated or robotic medical-device assembly lines.
• Experience with Ignition SCADA environments.
• Familiarity with GxP practices, computerized system validation, and applicable medical-device quality requirements.
• Experience validating vision inspection, device functional testing, serialization, or part-traceability systems.

Assignment Requirements

• Must be available to work onsite in Cambridge, Ontario.
• Candidates must already be local or willing to relocate temporarily to avoid recurring travel expenses.
• Two weeks of non-billable time are anticipated during the winter holiday period.
• Strong performers may be considered for an extension beyond the initial project stage.