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Computer System Validation Jobs in Wisconsin (NOW HIRING)

Medline

Validation Engineer

Hartland, WI

$73K - $110K/yr

... computer and test method validations of applicable products. * Validate new and revalidate as ... Perform engineering studies to determine if projects are feasible. * Assist with measurement system ...

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

... computer and test method validations of applicable products. * Validate new and revalidate as ... Perform engineering studies to determine if projects are feasible. * Assist with measurement system ...

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

... computer and test method validations of applicable products. * Validate new and revalidate as ... Perform engineering studies to determine if projects are feasible. * Assist with measurement system ...

Intellectt INC

Validation Engineer

Middleton, WI · On-site

The Validation Engineer will support validation of software systems and laboratory instrumentation, ensuring compliance with regulatory standards. This role involves executing performance ...

Centstone

Validation Engineer

Kenosha, WI · On-site

$50 - $55/hr

Validation Engineer Location: Kenosha, Wisconsin Pay Rate: $50/hr to 55/hr on C2C Schedule: Mostly overnight shifts, 12-hour shifts Openings: 5 Experience: 3+ years for Validation Engineer or 5+ ...

Centraprise Corp

BMS Validation Engineer

Glendale, WI

BMS Validation Engineer Job Location: Glendale, WI - Onsite Job Type: Fulltime Must Have Technical ... Experience in Battery Management System (BMS) ECU development. * Experience with Tools - Embedded ...

CAI

Validation Engineer

Kenosha, WI · On-site

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential ...

CAI

Validation Engineer

Kenosha, WI · On-site

$72K - $80K/yr

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential ...

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How much do computer system validation jobs pay per hour?

As of Jun 19, 2026, the average hourly pay for computer system validation in Wisconsin is $54.83, according to ZipRecruiter salary data. Most workers in this role earn between $42.21 and $65.05 per hour, depending on experience, location, and employer.

What are some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What is the salary of computer system validation?

The salary for a Computer System Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications such as GAMP or CSV training can influence earning potential, and roles often require knowledge of regulatory standards like FDA or ISO.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and compliance with regulations such as FDA or GMP.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It often requires knowledge of regulatory guidelines, validation protocols, and tools like GxP and 21 CFR Part 11. The field offers steady demand, opportunities for certification, and roles in quality assurance and compliance management.

Is CSV a skill?

In the context of Computer System Validation, CSV refers to Computer System Validation itself, which is a process rather than a skill. However, skills related to CSV include understanding validation protocols, regulatory requirements, and proficiency with validation tools and documentation. These skills are essential for professionals performing CSV tasks in regulated industries like pharmaceuticals and biotech.
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What job categories do people searching Computer System Validation jobs in Wisconsin look for? The top searched job categories for Computer System Validation jobs in Wisconsin are:
What cities in Wisconsin are hiring for Computer System Validation jobs? Cities in Wisconsin with the most Computer System Validation job openings:
Computer System Validation jobs near you
Manager, Data Integrity

Manager, Data Integrity

Arrowhead Pharmaceuticals

Verona, WI • On-site

Full-time

Posted 17 days ago

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
Serve as a hands-on team leader and subject matter expert supporting the company's data integrity and quality management programs across GxP operations. This role is responsible for executing assessments, driving remediation, and maintaining compliance with applicable data integrity frameworks and standards (e.g., 21 CFR Part 11, Annex 11, , PIC/S), while contributing to QMS program execution and compliant data management practices.. The role is expected to interact with multiple internal departments in support of data integrity management initiatives.
Responsibilities
  • Execute and support the implementation of data integrity policies, procedures, and program elements in alignment with global data integrity regulatory requirements; identify gaps and drive hands-on remediation.
  • Coordinate cross-functional data integrity activities, serving as a working-level point of contact to maintain program momentum and support peer teams in adopting compliant data management practices.
  • Conduct data integrity impact assessments, risk evaluations, and remediation plans; track progress and ensure timely closure of commitments.
  • Evaluate data management, documentation, and record control practices across systems and formats; flag non-conformances and support corrective action.
  • Assess computerized systems, software, and equipment for compliance with 21 CFR Part 11, Annex 11, and related guidance; document findings and support risk-based computer system validation and assurance activities (CSV/CSA).
  • Participate in and support data integrity audits and assessments; contribute to risk identification, gap analysis, and mitigation execution.
  • Author and execute CAPAs and process improvement initiatives to strengthen data integrity controls.
  • Manage and mentor direct reports to support professional development and build data integrity team capability.
  • Support in the development and delivery of data integrity training materials; serve as a go-to resource for team members on ALCOA++ principles, regulatory requirements, and compliant data practices.
  • Support regulatory inspections and partner audits as a subject matter contributor; prepare documentation and respond to data integrity inquiries.
  • Support ongoing data governance initiatives and compliant data management practices aligned with regulatory expectations.
  • Perform additional duties as assigned to support objectives.

Requirements:
  • Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline.
  • Minimum of five (5) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including demonstrated ability to coordinate or guide team-level work with increasing scope of responsibility.
  • Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
  • Demonstrated expertise with data integrity principles, data lifecycle management, and data governance frameworks.
  • Proven experience applying 21 CFR Part 11, Annex 11, and other relevant regulations and guidance governing data integrity and information security.
  • Strong understanding of information technology and data management systems, including system validation, security, and enterprise data governance.
  • Demonstrated ability to coordinate cross-functional tasks, build effective peer relationships, and advance data integrity objectives through influence without formal authority.
  • Detail-oriented and solutions-focused, with demonstrated ability to manage competing priorities, escalate risks appropriately, and deliver on commitments.
  • Strong written and verbal communication skills; able to translate technical compliance requirements into clear, actionable guidance for cross-functional teams.
  • Previous experience with the use of electronic document / quality management systems (EDMS / EQMS).
  • Ability for occasional business travel.

Preferred:
  • Advanced degree preferred.
  • Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent).

Wisconsin pay range
$115,000-$130,000 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.
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