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Computer System Validation Manager Jobs in Wisconsin

Inteldot

WI · On-site

Position Summary We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ...

Soltech PR

WI · On-site

$80 - $100/hr

The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle management of computerized systems within a regulated pharmaceutical/biotechnology manufacturing ...

Deloitte

System Test and Validation Lead

Milwaukee, WI · 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

Milwaukee, WI · 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

Milwaukee, WI · 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 ...

Perrigo

Associate Validation Scientist

Eau Claire, WI · On-site

Perform/manage annual CCP and OPRP testing as well as the annual cleaning verifications. Oversee all Computer System Validation protocol approvals and executions. Scope of the Role * Quality ...

Abbott

Validation Associate III

Madison, WI · On-site

... manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott ... Author validation plans, validation protocols, and validation summary reports for computer system ...

Abbott Laboratories

Validation Associate III

Madison, WI · On-site

$80 - $100/hr

... manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott ... Author validation plans, validation protocols, and validation summary reports for computer system ...

Abbott

Validation Associate III

Madison, WI · On-site

... manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott ... Author validation plans, validation protocols, and validation summary reports for computer system ...

RXinsider LTD.

Validation Associate III

Madison, WI · On-site

$80 - $100/hr

... manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott ... Author validation plans, validation protocols, and validation summary reports for computer system ...

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Computer System Validation Manager information

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$47.9K

$106.4K

$162K

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

As of Sep 9, 2026, the average yearly pay for computer system validation manager in Wisconsin is $106,401.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,200.00 and $133,200.00 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 the most commonly searched types of Computer System Validation jobs in Wisconsin?

The most popular types of Computer System Validation jobs in Wisconsin are:

What are popular job titles related to Computer System Validation Manager jobs in Wisconsin?

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

What job categories do people searching Computer System Validation Manager jobs in Wisconsin look for?

The top searched job categories for Computer System Validation Manager jobs in Wisconsin are:

What cities in Wisconsin are hiring for Computer System Validation Manager jobs?

Cities in Wisconsin 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 Wisconsin as of August 2026, with employment types broken down into 86% Full Time, 13% Part Time, and 1% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution, with an average salary of $106,401 per year, or $51.2 per hour.

Senior Computer System Validation (CSV) Engineer - Consultant

WI • On-site

Inteldot
See more jobs at Inteldotexternal

Other

Re-posted 16 hours ago

Job description

Position Summary

We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ideal candidate will have extensive experience validating computerized systems within the pharmaceutical or biotechnology industry and hands-on experience with Emerson DeltaV automation systems. The successful candidate will work closely with Engineering, Automation, Manufacturing, Quality Assurance, and IT teams to ensure computerized systems are validated and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 requirements.

Location: Texas (Onsite)

Administrative shiftResponsibilities
  • Lead Computer System Validation (CSV) activities for GMP computerized systems.
  • Develop, review, and execute validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
  • Validate automation systems, including Emerson DeltaV DCS, SCADA, and supporting infrastructure.
  • Support commissioning and qualification activities for new and existing manufacturing systems.
  • Perform impact assessments, change control evaluations, and periodic reviews.
  • Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements.
  • Collaborate with Automation, Engineering, IT, Manufacturing, and Quality teams during project execution.
  • Support audits and regulatory inspections by providing validation documentation and technical expertise.
  • Review system lifecycle documentation and maintain validated system status.
Required Qualifications
  • Bachelor’s degree in engineering, Computer Science, Information Systems, or related technical discipline.
  • 5+ years of Computer System Validation experience in the pharmaceutical, biotechnology, or medical device industry.
  • Hands-on experience validating Emerson DeltaV systems is required.
  • Strong understanding of GAMP 5, FDA regulations, cGMP, and 21 CFR Part 11.
  • Experience developing and executing IQ, OQ, and PQ protocols.
  • Experience with change control, deviation investigations, CAPA, and risk assessments.
  • Excellent technical writing and documentation skills.
  • Strong communication and cross-functional collaboration skills.
Preferred Qualifications
  • Experience with Manufacturing Execution Systems (MES), SCADA, PLCs, or process automation systems.
  • Knowledge of electronic batch records (EBR) and manufacturing systems integration.
  • Experience supporting commissioning, qualification, and validation (CQV) projects in biologics or sterile manufacturing environments.
Technical Skills
  • Emerson DeltaV (Required)
  • Computer System Validation (CSV)
  • GAMP 5
  • 21 CFR Part 11
  • cGMP/FDA Compliance
  • IQ/OQ/PQ Protocols
  • Risk Assessments
  • Change Control
  • CAPA
  • Commissioning & Qualification (CQV)
  • Automation Systems Validation
  • Technical Documentation
Preferred Industry Experience
  • Biotechnology
  • Pharmaceutical Manufacturing
  • GMP-Regulated Facilities
  • Cell & Gene Therapy or Biologics Manufacturing (preferred)
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