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Computer System Validation Engineer

EXOS (formerly Sondhi Solutions)

Indianapolis, IN

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JOB DETAILS
SKILLS
Application Programming Interface (API), Automation, Automation Engineering, Automation Systems, Biology, Biotech and Pharmaceutical, Change Control, Change Management, Code of Federal Regulations, Commissioning, Computer Skills, Computer Systems, Configuration Management, Control Systems, Data Analysis, Data Quality, Distributed Control Systems (DCS), Documentation, Drug Manufacturing, FDA Requirements, Functional Analysis, GMP (Good Manufacturing Practices), GxP, Home Automation, Human Machine Interface (HMI), IT Service Management (ITSM), Information Technology & Information Systems, Leadership, Manufacturing, Manufacturing Systems, Microsoft Excel, Microsoft Visio, Microsoft Word, Model Validation, Programmable Logic Controller (PLC), Property Management, Regulations, Requirements Management, Risk Analysis, Risk Modeling, ServiceNow, Software Development Lifecycle (SDLC), Software Patches, Standard Operating Procedures (SOP), System Lifecycle, System Validation, Systems Administration/Management, Systems Engineering, Test Design, Traceability, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Indianapolis, IN
POSTED
30+ days ago
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.


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.

About the Company

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EXOS (formerly Sondhi Solutions)

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