Carex is partnering with a Pharmaceuticals industry partner to find a Computer System Validation (CSV) Specialist to support validation and lifecycle activities for computerized systems, software, and IT infrastructure within a regulated environment. This role is embedded within a cGMP, GLP, and GCP-compliant Quality organization and will lead compliance oversight efforts across system assessments, testing, data governance, and validation documentation. The CSV Specialist will work cross-functionally to ensure systems are validated and maintained in accordance with regulatory expectations, supporting inspection readiness and audit activities. This is a Direct Hire role onsite in Madison, WI.
What You’ll Do
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Provide Quality oversight for CSV projects, including requirements engineering, system risk assessments, and data integrity evaluations.
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Review and approve validation documentation, such as Validation Plans, Risk Assessments, Functional Requirements, Testing Protocols, Trace Matrices, and Summary Reports.
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Act as the subject matter expert (SME) for Computer System Validation and remain current on evolving regulatory expectations.
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Ensure data integrity is maintained across all validation and system lifecycle documentation.
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Review and approve deviations, discrepancies, and change controls related to computerized systems.
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Coordinate validation activities with internal teams and external contractors, providing guidance where needed.
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Communicate CSV strategies during internal and external audits.
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Support regulatory inspections and ensure continuous inspection readiness.
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Review periodic validation assessments and develop remediation plans for any identified compliance gaps.
What You’ll Bring
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Bachelor’s degree in a scientific discipline.
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Minimum of 5 years’ experience in a pharmaceutical, biotech, contract manufacturing, or contract research organization with a focus on CSV, equipment, or instrument qualification.
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Strong understanding of GMP, GLP, FDA, EU, and ICH regulations as they apply to computer systems and validation.
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Quality-related certification such as CQA or CQMP preferred.
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Familiarity with electronic document management systems in a regulated environment is a plus.
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Ability to interpret regulatory standards and apply them to complex validation scenarios.
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Strong written and verbal communication skills and a collaborative, compliance-driven mindset.
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.
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