Job Summary We are seeking an experienced CSV (Computer System Validation) Engineer to support the validation and compliance of GxP-regulated computerized systems in a regulated pharmaceutical, biotech, medical device, or similar environment. The CSV Engineer will be responsible for developing and executing risk-based validation strategies, preparing validation documentation, performing testing, managing deviations and CAPAs, and ensuring computerized systems meet intended-use, regulatory, quality, and data integrity requirements.
Roles and Responsibilities
Develop and execute Computer System Validation (CSV) strategies, plans, protocols, test scripts, and validation reports.
Perform and document risk assessments, system impact assessments, traceability assessments, and change control activities.
Support validation of GxP-regulated computerized systems in accordance with applicable regulatory requirements, industry standards, and company procedures.
Execute and document validation test scripts, including identification and resolution of discrepancies and deviations.
Support deviation investigations, root-cause analysis, CAPA, and corrective actions related to computerized systems.
Ensure computerized systems comply with applicable FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
Apply risk-based validation methodologies throughout the system lifecycle.
Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
Collaborate closely with Quality Assurance, IT, Engineering, Manufacturing, Validation, and business stakeholders to ensure systems meet intended-use and compliance requirements.
Review system documentation, test evidence, configuration records, and other validation deliverables for completeness and compliance.
Support audit and inspection readiness by providing validation documentation, test evidence, and compliance records.
Identify validation gaps and support remediation activities to maintain the validated state of computerized systems.
Education & Experience
Bachelor's degree in computer science, Information Technology, Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field.
A master's degree or relevant professional certification in validation, quality, compliance, or a related discipline is a plus.
3+ years of experience in Computer System Validation (CSV), IT validation, or a closely related validation/compliance role within a regulated environment.
Experience working in pharmaceutical, biotechnology, medical device, healthcare, or other GxP-regulated industries.
Hands-on experience developing and executing validation documentation, protocols, and test scripts.
Numbers & Facts
Location
plymouth, MN
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Computer Scienceunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Data Qualityunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Healthcareunmatched
Industry Standardsunmatched
Information Technology & Information Systemsunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Riskunmatched
Risk Analysisunmatched
Root Cause Analysisunmatched
Strategic Planningunmatched
System Lifecycleunmatched
System Testunmatched
System Validationunmatched
Systems Administration/Managementunmatched
Systems Analysisunmatched
Test Scriptsunmatched
Testingunmatched
Traceabilityunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched
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