Computer System Validation Engineer

Job Description

Position Overview:

The Computer Systems Validation Engineer supports validation lifecycle activities for automation and control systems within a regulated pharmaceutical manufacturing environment. This role works onsite at the customer manufacturing facility and collaborates closely with Automation Engineering, Information Technology, and site leadership to ensure systems remain in a validated state and compliant with global regulatory expectations.

Responsibilities:

• Lead computer systems validation lifecycle activities for automation and control systems, including distributed control systems, programmable logic controllers, human machine interfaces, building management systems, and historian platforms.
• Develop and execute validation plans, user requirements, functional specifications, design specifications, and configuration specifications for automation systems.
• Author and execute installation qualification, operational qualification, and performance qualification protocols.
• Generate and maintain requirements traceability matrices linking requirements through design, testing, and acceptance.
• Author validation summary reports documenting validation outcomes, deviations, and acceptance rationale.
• Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance.
• Conduct risk assessments, including GAMP 5 categorization and functional risk assessments.
• Manage validation change control by assessing the impact of system changes, patches, and upgrades on the validated state.
• Support periodic review activities to confirm systems remain in a validated state.
• Define and execute the computer systems validation scope for the ServiceNow platform in collaboration with process owners.
• Validate integrations between automation platforms and ServiceNow, including event connectors, configuration management database connectors, application programming interfaces, and access provisioning workflows.
• Draft and maintain standard operating procedures related to computer systems validation.
• Support audit readiness activities to ensure inspection-ready documentation aligned with FDA and EMA regulatory expectations.
• Provide support for data integrity assessments across automation and historian systems as needed.
• Assist with commissioning and qualification activities for new automation equipment.
• Support remediation of validation findings from audits or regulatory inspections.
• Advise on validation strategy for future automation system upgrades and expansions.

Job Requirements

Required:

• Demonstrated experience in computer systems validation for automation and control systems in a pharmaceutical or GMP regulated environment.
• Strong knowledge of GAMP 5 methodology, validation lifecycle models, and risk-based validation approaches.
• Experience with 21 CFR Part 11 compliance for electronic records and electronic signatures.
• Proficiency in developing validation deliverables across the system development lifecycle.
• Experience working with automation systems in a manufacturing environment.
• Strong understanding of FDA and EMA regulatory expectations for computerized system validation.

Preferred:

• Experience with ServiceNow platform validation or information technology service management system validation in a GxP environment.
• Experience validating distributed control systems, historian platforms, or building automation systems.
• Familiarity with data integrity principles including ALCOA plus.
• Experience with electronic validation management systems such as Kneat or ValGenesis.
• Life sciences manufacturing experience including biologics or advanced therapies.
• Proficiency with Microsoft Word, Excel, and Visio for validation documentation and diagrams.