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Computer System Validation Manager Jobs in Merrillville, IN

Compsciprep LLC

CSV Validation Consultant

Chicago, IL · On-site

Computer System Validation (CSV) / Validation Consultant - Life Sciences Location: Multiple ... Knowledge of CTMS (Clinical Trial Management System) * Preparation and review of validation ...

New

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Chicago, IL · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Kett Engineering

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Autonomous Systems Validation Operator

Chicago, IL · On-site

$24 - $27/hr

Manage onboard logging equipment, record system performance data, and verify data transfer for ... Must hold a valid Driver's License in the state of residence. * Clean driving record: No ...

Kett Engineering

Be Seen First

Autonomous Systems Validation Operator

Chicago, IL · On-site

$24 - $27/hr

Manage onboard logging equipment, record system performance data, and verify data transfer for ... Must hold a valid Driver's License in the state of residence. * Clean driving record: No ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site

Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance ...

Danaher

Senior Engineer, Process Validation

Chicago, IL · On-site +1

$100K - $130K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact ... This position reports to the Process Validation Manager and is part of the Technical Operations ...

Danaher

Senior Engineer, Process Validation

Chicago, IL · On-site +1

$100K - $130K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact ... This position reports to the Process Validation Manager and is part of the Technical Operations ...

Pwc

Data Validation Risk - Manager

Chicago, IL

$99K - $232K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... entire system, take ownership of projects, and develop skills outside your comfort zone ... Accounting, Engineering, Data Processing/Analytics/Science, Computer and Information Science ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Merrillville, IN

Computer System Validation Manager information

See Merrillville, IN salary details

$46.6K

$103.4K

$157.4K

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

As of Aug 13, 2026, the average yearly pay for computer system validation manager in Merrillville, IN is $103,406.00, according to ZipRecruiter salary data. Most workers in this role earn between $73,100.00 and $129,500.00 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 cities near Merrillville, IN are hiring for Computer System Validation Manager jobs?

Cities near Merrillville, IN with the most Computer System Validation Manager job openings:

Computer System Validation Manager jobs near you

CSV Validation Consultant

Compsciprep LLC

Chicago, IL • On-site

Other

Posted 2 days ago

New

Job description

Hi,                                      

 
Greetings from CompSciPrep!!!
 
We have an immediate opening for a position with one of our prestigious clients that may interest you.
 
Below is the job description for your reference. Please go through it and let me know your thoughts so that we can move forward.
 
Job Description:
 
Role: Computer System Validation (CSV) / Validation Consultant – Life Sciences
Location: Multiple Location 
 
Summary:
We are looking for an experienced Computer System Validation (CSV) Consultant with strong experience in Life Sciences/Pharmaceutical domain. The ideal candidate should have hands-on expertise in validating GxP regulated systems, ensuring regulatory compliance, and supporting clinical and quality applications.
 
Must Have Skills
  • 8+ years of experience in Computer System Validation (CSV)
  • Strong understanding of GxP, 21 CFR Part 11, GAMP 5, FDA regulations
  • Experience in IT Compliance and validation lifecycle
  • Validation of IT Systems and regulated applications
  • Hands-on experience with Veeva Quality Docs
  • Experience with JIRA and HP ALM
  • Validation of Safety Systems
  • Experience with Argus Safety
  • Experience with Veeva Vault
  • Experience working on Clinical Trial Systems
  • Knowledge of CTMS (Clinical Trial Management System)
  • Preparation and review of validation documents (URS, IQ, OQ, PQ, RTM, Validation Plan, Validation Summary Report)
  • Strong communication and stakeholder management skills
Preferred Skills
  • ISO 13485 / Quality Management exposure
  • Clinical, Quality, and Pharmacovigilance system validation
  • Experience working with global pharmaceutical clients
  • Knowledge of SDLC and Agile methodology
Responsibilities
  • Execute end-to-end Computer System Validation activities.
  • Prepare and review validation documentation.
  • Ensure systems comply with GxP and regulatory requirements.
  • Coordinate with business, QA, IT, and vendors during validation.
  • Support audits and compliance activities.
  • Validate clinical, quality, and safety applications.
 
 

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