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Computer System Validation Manager Jobs in Merrillville, IN

OnShore Technology Group

Sr. Validation Lead

Chicago, IL · On-site

... Management System (EVMS) of its kind to include a validation Kanban board and seamless integration ... This position requires a senior-level individual with strong experience in supporting computer ...

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

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 +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 ...

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 ...

Southern Research

Senior Validation Analyst

Chicago, IL · On-site

$119K - $120K/yr

Lead system validation efforts, including validation strategy, risk management approach, and ... Bachelor's degree in computer science or life sciences, other related field, or equivalent ...

Valspec

CSV Lead

Chicago, IL · On-site

$105K - $139K/yr

... CSV (Computer System Validation) Lead to support automation and digital systems validation on a major greenfield pharmaceutical manufacturing program. What You'll Do * Manage CSV execution and ...

Danaher

Senior Engineer, Process Validation

Chicago, IL · On-site +1

$100K - $130K/yr

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

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 ...

Southern Research

Application Administrator

Chicago, IL · On-site

User Access Management: Provision user accounts, assign roles and manage permissions. * System ... Contribute and support computer system validation projects, including application change control as ...

Deloitte

Model Validation Senior Manager

Chicago, IL · On-site

Undergraduate degree in Computer Science, Data Science, Artificial Intelligence, Applied ... Regulatory & Financial Risk - Senior Manager - Model Validation Our Deloitte Regulatory, Risk ...

SPX

Mgr, Control Systems

Michigan City, IN

Oversee system validation efforts to ensure performance, reliability, and compliance requirements ... Advanced degree in Engineering, Computer Science, or Business Administration preferred.

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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 Sep 14, 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 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 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 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 popular job titles related to Computer System Validation Manager jobs in Merrillville, IN?

For Computer System Validation Manager jobs in Merrillville, IN, the most frequently searched job titles are:

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

Sr. Validation Lead

Chicago, IL • On-site

OnShore Technology Group
IT Services • 1 - 10 employees
Learn more about OnShore Technology Groupexternal

Other

Posted 12 days ago

Job description

For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.

OnShore’s leading innovation is ValidationMaster™, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.

The Sr. Validation Lead is primarily responsible for oversight of V&V activities for designated computerized system implementation projects. This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for applications used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs.

ROLES & RESPONSIBILITIES
  • Ability to lead and coordinate multiple CSV projects
  • Develop / review validation test protocols as required using automated technology tools
  • Coordinate / communicate with other departments, SMEs
  • Ensure that all validation deliverables are prepared in accordance with internal guidelines, policies and procedures
  • Create, track and manage all validation project plans
  • Provide regulatory guidance on principles of CSV to the expanded team
EDUCATION & CERTIFICATION
  • B.S. or equivalent in computer science, engineering, life sciences, or related field
  • Minimum 10 years of experience in software quality assurance in the life sciences industry in a leadership role
  • ASQ CSQE Certification or equivalent preferred
  • Practical working knowledge of software development and implementation methodologies
  • Experience with the validation of Enterprise Resource Planning (ERP) systems is preferred.
  • Strong oral and written communication skills in English.
  • Excellent interpersonal skills.
  • Advanced skills at team management, organization, and communication of priorities and listening
  • Practical experience in conducting and supporting CSV audits and inspections.
  • Advanced proficiency in the use of Microsoft Office desktop applications
REGULATORY KNOWLEDGE REQUIREMENTS
  • U.S. FDA Validation Guidance Document
  • 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule
  • U.S. FDA Data Integrity Guidance
  • NIST Cybersecurity Framework
  • 21 CFR Part 210/211 cGMP
  • EUDRALEX Annex 11 Rules Governing Medicinal Products in the EU, Volume 4
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