Industrial Automation and CSV Engineer
No salary listed
Senior
Cambridge, ON, Canada
In PersonMust work onsite in Cambridge, Ontario; local candidates or temporary relocation is required.
Manufacturing Quality & TestValidation, Compliance & Quality Systems
About the job
Requirements
- A minimum of six years of experience working with programmable logic controller- and supervisory control and data acquisition-controlled industrial automation or assembly equipment.
- Experience in a regulated manufacturing environment.
- Demonstrated expertise authoring and executing Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, and Test Method Validation protocols.
- Strong understanding of the software verification and validation lifecycle.
- Advanced knowledge of programmable logic controller 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 programmable logic controller logic, electrical drawings, functional specifications, and equipment design documentation.
- Strong technical writing, troubleshooting, and cross-functional communication skills.
- Availability to work onsite in Cambridge, Ontario.
- Must already be local to Cambridge or be willing to relocate temporarily.
Responsibilities
- Author, review, and execute Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, and Test Method Validation protocols.
- Plan and perform software verification and validation activities throughout the system lifecycle.
- Test programmable logic controller 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 programmable logic controller programs, supervisory control and data acquisition configurations, automation architecture, control narratives, and electrical documentation.
- Document test results, discrepancies, objective evidence, and deviations accurately.
- Collaborate with equipment suppliers, controls engineers, quality, manufacturing, and project stakeholders.
- Support troubleshooting, deviation resolution, corrective actions, and protocol closeout.
Desired Qualifications
- Medical-device assembly or manufacturing experience.
- Experience validating automated or robotic medical-device assembly lines.
- Experience with Ignition supervisory control and data acquisition 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.
About the company
VTI Life Sciences provides validation and compliance services across the pharmaceutical and biotech sectors. They offer a full range of services including computer validation, cleaning validation, process validation, clean room certification, temperature mapping, and qualification of processes, equipment, and facilities. Their work involves conducting and documenting tests, audits, and qualifications to show a facility and its systems meet regulatory standards and quality requirements. The company differentiates itself through its ISO 9001:2000 certification, a commitment to quality, personalized support, and a network of offices in San Diego, San Francisco, Boston, and China that enable broad client coverage. The overall goal is to help clients ensure their operations and facilities comply with industry regulations and operate reliably and safely.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
San Diego, California
Founded
1998
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Simplify's Take
What believers are saying
- Validation.org added FDA 483 response, warning-letter, and consent-decree remediation services in 2026.
- Recent postings show active hiring for CQV and ELN validation projects in Los Angeles and Korea.
- LinkedIn and validation.org highlight AI, GxP training, and automation messaging, broadening deal flow.
What critics are saying
- ZipRecruiter shows contract CQV roles, signaling project churn and utilization risk in 2026.
- The business depends on regulated manufacturing demand and client audits, tightening budgets quickly.
- An existential risk hits if FDA compliance work shifts in-house or to larger consultancies.
What makes VTI Life Sciences unique
- Founded 1996, VTI offers CQV, CSV, automation, and FDA 483 response services.
- Validation.org lists 27 years of cGMP, GLP, and computerized systems validation experience.
- Offices span San Diego, Boston, North Carolina, Canada, China, Singapore, and Thailand.
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Benefits
- Remote Work Options
- 401(k) Company Match
- Professional Development Budget