About this opportunity
Katalyst CRO lists this CSV Specialist opportunity in madison, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
Job Description
We are seeking a CSV Specialist to support Computer System Validation (CSV) activities for GxP 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.
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Worksite address
madison, WI, 53774, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.