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Computer System Validation Jobs in Indiana (NOW HIRING)

CAI

Computer Systems Validation Engineer

Indianapolis, IN

$75K - $106K/yr

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

Valspec

Validation Engineer

Indianapolis, IN

Requirements * 3+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV and/or Syncade experience ...

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How much do computer system validation jobs pay per hour?

As of May 30, 2026, the average hourly pay for computer system validation in Indiana is $51.69, according to ZipRecruiter salary data. Most workers in this role earn between $39.81 and $61.30 per hour, depending on experience, location, and employer.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What are some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
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Computer System Validation jobs near you
Computer System Validation Engineer

Computer System Validation Engineer

EXOS (formerly Sondhi Solutions)

Indianapolis, IN

Full-time

Posted 7 days ago

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.

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.