Job Description:
We are seeking a CSV Specialist to support Computer System Validation (CSV) activities for GxP-regulated systems in the pharmaceutical, biotechnology, or medical device industry. The ideal candidate will be responsible for ensuring computerized systems are validated and compliant with regulatory requirements, company procedures, and industry standards. Responsibilities:
Execute and support Computer System Validation (CSV) activities for GxP systems.
Develop, review, and maintain validation documentation, including:
Validation Plans
User Requirements Specifications (URS)
Functional Specifications (FS)
Risk Assessments
IQ/OQ/PQ Protocols
Validation Reports
Perform system impact assessments and risk-based validation activities.
Support testing activities, including protocol execution and defect tracking.
Ensure compliance with FDA 21 CFR Part 11, GAMP 5, GMP, and Data Integrity requirements.
Collaborate with Business, IT, QA, and Engineering teams throughout the system lifecycle.
Support change controls, deviations, CAPAs, and periodic reviews.
Maintain validation records within electronic document management systems.
Participate in internal audits and regulatory inspections.
Requirements:
Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.
3+ years of CSV experience in a regulated pharmaceutical, biotechnology, or medical device environment.
Knowledge of GAMP 5, FDA 21 CFR Part 11, GMP, and Data Integrity (ALCOA+) principles.
Experience with validation documentation and testing activities.
Familiarity with electronic quality management and document management systems.
Strong technical writing and communication skills.
Preferred Qualifications:
Experience with CSA (Computer Software Assurance) methodologies.
Knowledge of systems such as:
TrackWise
Veeva
SAP
LIMS
MES
Empower
SharePoint
ServiceNow
Jira
Experience supporting regulatory audits and inspections.
Numbers & Facts
Location
Madison, WI
Skills
Atlassian JIRAunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Bug Tracking/Defect Managementunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Scienceunmatched
Computer Skillsunmatched
Computer Softwareunmatched
Computer Systemsunmatched
Data Qualityunmatched
Document Managementunmatched
Electronic Document and Records Management System (EDRMS)unmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Industry Standardsunmatched
Information Technology & Information Systemsunmatched
Internal Auditunmatched
Laboratory Information Management System (LIMS)unmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Microsoft SharePointunmatched
Pharmacyunmatched
Process Validationunmatched
Quality Assuranceunmatched
Quality Managementunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Riskunmatched
Risk Analysisunmatched
SAPunmatched
ServiceNowunmatched
System Lifecycleunmatched
System Validationunmatched
Systems Analysisunmatched
Technical Writingunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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