Senior CSV Validation Engineer - Pharma industry

Title: Senior CSV Validation Engineer

Industry: Pharmaceutical

Location: Ontario, Canada

Experience: 6+ years

Job Summary:

Our client is seeking a Senior CSV Validation Specialist dedicated to Building Management System validation activities. This is an on-site role supporting a regulated pharmaceutical manufacturing environment. The role supports the Site Automation Engineering organization and works closely with automation engineers, IT, system integrators, and site leadership to ensure systems are validated and maintained in a compliant state.

Roles & Responsibilities:

• Lead the Building Management System validation lifecycle across all buildings from User Requirement Specification authoring through Validation Summary Report and closeout.
• Develop and execute Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols using a risk-based approach aligned with quality procedures.
• Generate and maintain Requirements Traceability Matrices linking requirements through design, testing, and acceptance.
• Author Validation Summary Reports documenting validation activities, deviations, resolutions, and acceptance rationale.
• Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance across Metasys and AVEVA PI systems.
• Coordinate with Integration Engineering resources to support alarm management validation aligned with ISA 18.2 and operational technology cybersecurity validation aligned with ISA IEC 62443.
• Validate OPC UA integrations between Metasys, AVEVA PI, and DeltaV.
• Draft and maintain Standard Operating Procedures related to Building Management System operations, operator training, and preventive maintenance.
• Enroll validated systems into the periodic review program to support ongoing maintenance of the validated state.
• Support audit readiness activities by ensuring validation documentation is inspection-ready and aligned with FDA, EMA, and corporate quality standards.
• Provide additional support for data integrity assessments, commissioning and qualification activities, remediation of validation findings, and validation strategy development for future system upgrades as needed.

Required qualifications:

• Demonstrated experience performing computer systems validation for building management or control systems within a pharmaceutical or GMP-regulated environment.
• Strong working knowledge of GAMP 5 methodology, V model lifecycle concepts, and risk-based validation approaches.
• Hands-on experience supporting 21 CFR Part 11 compliance assessments for electronic records, electronic signatures, and audit trails.
• Solid understanding of FDA and EMA regulatory expectations related to computerized system validation.
• Direct experience validating Johnson Controls Metasys, Honeywell, Siemens, or similar Building Management System platforms.
• Experience validating AVEVA PI Historian, DeltaV systems, or OPC UA integrations.
• Familiarity with ISA 18.2 alarm management principles and ISA IEC 62443 cybersecurity standards.
• Knowledge of data integrity principles, including ALCOA plus and data governance practices.