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Validation Scientist Jobs in Wisconsin (NOW HIRING)

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

The Data Scientist serves as a solution developer within the North America Regional Product-Oriented Delivery (POD) team, designing and validating advanced analytical and machine learning solutions ...

New

The Data Scientist serves as a solution developer within the North America Regional Product-Oriented Delivery (POD) team, designing and validating advanced analytical and machine learning solutions ...

New

The Data Scientist serves as a solution developer within the North America Regional Product-Oriented Delivery (POD) team, designing and validating advanced analytical and machine learning solutions ...

New

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Showing results 21-40

Validation Scientist information

See Wisconsin salary details

$22

$52

$78

How much do validation scientist jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for validation scientist in Wisconsin is $52.48, according to ZipRecruiter salary data. Most workers in this role earn between $39.81 and $63.80 per hour, depending on experience, location, and employer.

What is a validation scientist?

Validation Scientists are professionals responsible for ensuring that processes, equipment, and systems in industries like pharmaceuticals, biotechnology, and manufacturing meet regulatory and quality standards. They design and execute validation protocols to confirm that products are consistently produced and controlled according to set specifications. Their work is critical for maintaining product safety, efficacy, and compliance with industry regulations. Validation Scientists often collaborate with quality assurance, engineering, and production teams to troubleshoot issues and implement improvements.

What are the key skills and qualifications needed to thrive as a validation scientist?

To thrive as a Validation Scientist, you need a strong background in life sciences or engineering, with knowledge of regulatory standards like GMP and experience in method or process validation. Familiarity with validation software, data analysis tools, and documentation systems is typically required, along with certifications such as Six Sigma or ASQ CQA being advantageous. Attention to detail, problem-solving abilities, and effective communication are standout soft skills in this role. These competencies are crucial for ensuring compliance, product quality, and successful audits in highly regulated environments.

What are some common challenges faced by validation scientists when working on new product launches?

Validation Scientists often encounter challenges such as tight project timelines, evolving regulatory requirements, and the need to coordinate with multiple departments including R&D, Quality Assurance, and Manufacturing. Managing documentation and ensuring all validation protocols and reports meet industry standards can also be demanding, especially in highly regulated environments like pharmaceuticals or biotechnology. Successful Validation Scientists develop strong project management and communication skills to navigate these complexities and ensure smooth product launches.

What are popular job titles related to Validation Scientist jobs in Wisconsin?

For Validation Scientist jobs in Wisconsin, the most frequently searched job titles are:

Infographic showing various Validation Scientist job openings in Wisconsin as of August 2026, with employment types broken down into 89% Full Time, 7% Part Time, and 4% Contract. Highlights an 83% Physical, 5% Hybrid, and 12% Remote job distribution, with an average salary of $109,164 per year, or $52.5 per hour.

Senior Manager, GxP Systems & Validation

Arrowhead Pharmaceuticals

Verona, WI • On-site

Full-time

Re-posted 22 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
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.
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