ZipRecruiter

Log In

1

System Validation Jobs in Madison, WI (NOW HIRING)

Pfizer

Validation Engineer

Middleton, WI · On-site

$68K - $114K/yr

In this role, you will help ensure equipment, processes, and systems meet regulatory requirements ... Troubleshoot validation problems for equipment and performance processes, conducting statistical ...

Posted today

Abbott

Validation Associate III

Madison, WI · On-site

The crucial information derived from our tests, instruments, and informatics systems is often the ... As the Validation Associate III, you'll have the chance to participate or lead a variety of ...

RXinsider LTD.

Validation Associate III

Madison, WI · On-site

The crucial information derived from our tests, instruments, and informatics systems is often the ... As the Validation Associate III, you'll have the chance to participate or lead a variety of ...

Abbott

Validation Associate III

Madison, WI · On-site

The crucial information derived from our tests, instruments, and informatics systems is often the ... As the Validation Associate III, you'll have the chance to participate or lead a variety of ...

Haast Autonomous

Flight Systems Engineer

Oregon, WI · On-site

Prepare aircraft for flight tests through parameter reviews, pre-flight checks, and system validation * Collaborate with mechanical, simulation, and flight-test engineers to improve reliability

next page

Showing results 1-20

All JobsSystem Validation JobsSystem Validation Jobs in Madison, WI

System Validation information

See Madison, WI salary details

$29

$52

$76

How much do system validation jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for system validation in Madison, WI is $52.20, according to ZipRecruiter salary data. Most workers in this role earn between $39.23 and $64.90 per hour, depending on experience, location, and employer.

What is the difference between System Validation vs Quality Assurance Specialist?

AspectSystem ValidationQuality Assurance Specialist
CredentialsTypically requires engineering or technical degrees, certifications like ISTQB or ISO auditorRequires quality management certifications, such as ASQ CQE or Six Sigma
Work EnvironmentFocuses on testing and verifying systems, often in manufacturing, software, or medical device industriesInvolves process audits, documentation, and compliance across various industries
Employer & Industry UsageUsed in regulated industries like healthcare, aerospace, and software developmentCommon in manufacturing, software, and service industries for maintaining quality standards

System Validation and Quality Assurance Specialists both ensure product quality but differ in scope. System Validation primarily verifies that systems meet specifications, while Quality Assurance focuses on process improvement and compliance. Understanding these roles helps in choosing the right career path or hiring the right professional.

Is computer system validation a good field?

Computer system validation is a specialized field within quality assurance and regulatory compliance, primarily in industries like pharmaceuticals and biotech. It involves ensuring that computer systems meet regulatory standards through documentation, testing, and validation protocols, often requiring knowledge of GxP guidelines and validation tools. The field offers steady demand and opportunities for growth with relevant certifications and technical skills.

What is the job description of system validation?

System validation involves testing and verifying that a system or product meets specified requirements and functions correctly in its intended environment. It includes designing validation protocols, executing tests, analyzing results, and ensuring compliance with industry standards, often using tools like test management software. Professionals in this role need strong analytical skills and knowledge of quality assurance processes.
System Validation jobs near you
Infographic showing various System Validation job openings in Madison, WI as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, 2% Temporary, and 2% Contract. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution, with an average salary of $108,569 per year, or $52.2 per hour.

Senior Manager, GxP Systems & Validation

Verona, WI • On-site

Arrowhead Pharmaceuticals
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees
Learn more about Arrowhead Pharmaceuticalsexternal

Full-time

Re-posted yesterday

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI.  Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 

The Position

The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA).

This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.

Responsibilities

Strategic Leadership & Governance

  • Maintain governance frameworks for GxP computerized systems
  • Define validation strategies aligned with GAMP 5 and CSA principles
  • Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
  • Serve as system owner and system administrator for critical GxP platforms
  • Maintain validation and system lifecycle policies and standards
  • Participates in continuous improvement of validation methodologies, templates, and risk-based approaches
  • Provide compliance guidance to executive leadership and functional heads

System Lifecycle Oversight

  • Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms)
  • Ensure systems remain validated, secure, and audit-ready throughout implementation, upgrades, and decommissioning
  • Approve system configurations, changes, and access governance frameworks
  • Ensure robust data integrity controls in accordance with ALCOA+ principles
  • Monitor system performance, audit trails, cybersecurity controls, and vendor compliance

Validation Program Leadership

  • Lead enterprise validation initiatives across multiple concurrent projects
  • Oversee development and approval of validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability, Summary Reports)
  • Ensure appropriate application of risk-based validation and CSA methodologies
  • Manage validation master planning and resource allocation
  • Provide oversight of regression testing and revalidation strategies
  • Ensure validation documentation supports global inspection readiness
  • Act as SME during regulatory inspections and internal audits
  • Oversee remediation efforts related to audit findings, deviations, and CAPAs
  • Maintain awareness of evolving global regulatory expectations

Project & Vendor Management

  • Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners
  • Oversee third-party vendors and validation consultants
  • Manage budgets, timelines, risks, and resource planning for validation programs
  • Drive issue resolution and escalation management
  • Ensure vendor deliverables meet compliance and quality standards

People & Organizational Development

  • Lead, mentor, and develop validation and system administration staff
  • Establish performance expectations and competency development plans
  • Build scalable team capabilities to support business growth

Requirements

  • Bachelor's degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred)
  • 8+ years of experience in GxP computerized systems and validation
  • 3+ years in a leadership or program management role
  • Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements
  • Demonstrated experience leading complex, enterprise-level system implementations
  • Strong understanding of change control, deviation management, CAPA, and quality systems
  • Proven ability to influence senior stakeholders and drive cross-functional alignment

Preferred

  • PMP or equivalent project management certification
  • GAMP, ITIL, or related compliance certification
  • Experience leading CSA transformation initiatives
  • Extensive experience related to administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson)
  • Pharmaceutical or CRO experience
  • Prior regulatory inspection leadership experience
  • Risk-based decision making
  • Continuous improvement mindset
Wisconsin pay range
$145,000—$165,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.   

Candidates must have current, valid authorization to work in the country where this role is located.

California Applicant Privacy Policy