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Computer System Validation Csv Pharmaceutical Jobs in Wisconsin

Merz North America

Sr Applications Quality Engineer

Racine, WI · On-site

$83K - $112K/yr

Lead in the planning, development, and implementation of computer systems validation documentation ... Serve as the CSV representative during regulatory inspections. * Own the full project lifecycle for ...

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

... pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820 ... Perform engineering studies to determine if projects are feasible. Assist with measurement system ...

Medline Industries, LP

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

... pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820 ... Perform engineering studies to determine if projects are feasible. * Assist with measurement system ...

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

... pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820 ... Perform engineering studies to determine if projects are feasible. * Assist with measurement system ...

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

... pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820 ... Perform engineering studies to determine if projects are feasible. * Assist with measurement system ...

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

... pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820 ... Perform engineering studies to determine if projects are feasible. * Assist with measurement system ...

Medline International Two Australia Pty

WI · On-site

$73 - $110/hr

... pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820 ... Perform engineering studies to determine if projects are feasible.* Assist with measurement system ...

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Computer System Validation Csv Pharmaceutical information

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

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

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

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Cities in Wisconsin with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Wisconsin as of August 2026, with employment types broken down into 33% Full Time, and 67% Contract. Highlights an 100% In-person job distribution.

Senior Manager, GxP Systems & Validation

Arrowhead Pharmaceuticals

Verona, WI • On-site

Full-time

Re-posted 10 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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