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Computer System Validation Manager Jobs in Indiana

EXOS

Senior Automation Engineer

Indianapolis, IN · On-site

$99.40K - $130.50K/yr

... Management Systems in a heavily regulated manufacturing environment. This role will work closely ... Support Computer System Validation activities, including Installation Qualification, Operational ...

Lilly

Associate Director Data and Systems QA

Lebanon, IN

$123K - $180.40K/yr

Strong knowledge of Computer System Validation, Data Integrity/Management, Quality Management Systems, and applicable regulatory requirements * Demonstrated problem solving and decision-making skills

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$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.
Senior Automation Engineer

Senior Automation Engineer

EXOS (formerly Sondhi Solutions)

Indianapolis, IN • On-site

$99.40K - $130.50K/yr

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Position Overview:
The Senior Automation Engineer will be responsible for the design, configuration, review, commissioning, and validation support of the Building Management Systems in a heavily regulated manufacturing environment. This role will work closely with engineering, quality, operations, vendors, and project teams to ensure compliant and reliable BMS solutions across the project lifecycle.
Responsibilities:
  • Configure and program Rockwell Automation and Johnson Controls Metasys BMS controllers.
  • Define control logic for HVAC, utilities, and environmental monitoring systems.
  • Develop and review system architecture, integration designs, and control strategies.
  • Perform peer code reviews for BMS applications and ensure adherence to code standards and naming conventions.
  • Identify and resolve logic and configuration issues before testing and commissioning.
  • Lead or support BMS commissioning activities, including functional testing and loop checks.
  • Coordinate with vendors, contractors, and site-based engineering teams.
  • Support Computer System Validation activities, including Installation Qualification, Operational Qualification, and Performance Qualification.
  • Execute and review system verification and validation test scripts.
  • Raise, track, and resolve deviations identified during qualification and testing.
  • Develop User Requirements Specifications, Functional Specifications, and configuration specifications.
  • Author Standard Operating Procedures and work instructions for BMS operations and maintenance.
  • Develop validation plans, protocols, and summary reports.
  • Collaborate across multidisciplinary project teams and interface with Quality Assurance, Engineering, and Operations.
  • Provide technical guidance and mentorship to junior engineers.

Required Qualifications:
  • Experience with Rockwell Automation platforms and/or Johnson Controls Metasys systems.
  • Background in systems commissioning and qualification activities.
  • Experience developing and reviewing GMP system documentation.
  • Ability to work effectively in a fast-paced project-driven environment.
  • Experience supporting Computer System Validation and system verification efforts.
  • Demonstrated experience performing BMS code reviews.
Preferred Qualifications:
  • Direct experience validating Johnson Controls Metasys, Honeywell, Siemens, or similar BMS platforms.
  • Experience with AVEVA PI Historian, DeltaV, or OPC UA integration validation.
  • Familiarity with ISA 18.2 alarm management practices and ISA IEC 62443 cybersecurity standards.
  • Knowledge of data integrity principles, including ALCOA Plus and data governance frameworks.
  • Experience using Kneat, ValGenesis, or similar electronic validation management systems.
  • Experience in pharmaceutical or life sciences manufacturing environments, including biologics, advanced therapies, or greenfield facility commissioning.
  • Proficiency with Microsoft Word, Visio, and Excel for developing validation documentation and technical diagrams.