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Computer System Validation Manager Jobs in Indiana

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

Catapult

Senior Validation Manager

Princeton, IN · On-site

... laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic ... Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the ...

Valspec

Validation Engineer

Indianapolis, IN

... computer systems validation and system life cycle management. We are motivated to identify those that share our passion and can mirror the level of energy we put into ensuring that we remain on the ...

INCOG

Process Validation Manager

Fishers, IN · On-site

TSMS - Manager of Process Validation The Technical Services and Manufacturing Sciences (TSMS ... If you crave the challenge of creating systems from scratch and believe you have insights for a ...

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Computer System Validation Manager information

See Indiana salary details

$45.2K

$100.3K

$152.7K

How much do computer system validation manager jobs pay per year?

As of May 30, 2026, the average yearly pay for computer system validation manager in Indiana is $100,309.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,900.00 and $125,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Indiana? The most popular types of Computer System Validation jobs in Indiana are:
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What job categories do people searching Computer System Validation Manager jobs in Indiana look for? The top searched job categories for Computer System Validation Manager jobs in Indiana are:
What cities in Indiana are hiring for Computer System Validation Manager jobs? Cities in Indiana with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Indiana as of May 2026, with employment types broken down into 24% Full Time, 68% Part Time, and 8% Contract. Highlights an 85% Physical, and 15% Remote job distribution, with an average salary of $100,309 per year, or $48.2 per hour.
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.