CSV Specialist

Katalyst CRO; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a CSV Specialist to support Computer System Validation (CSV) activities for GxP systems in the pharmaceutical, biotechnology, or medical device industry in Madison, WI. The candidate will ensure computerized systems are validated and compliant with regulatory requirements, company procedures, and industry standards.

The role involves developing validation documentation, collaborating with IT, QA, and engineering, and supporting audits and inspections to maintain data

Qualifications

• Bachelor's degree in engineering, life sciences, 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.

Responsibilities

• Execute and support CSV activities for GxP systems.
• Develop, review, and maintain validation documentation (Validation Plans, URS, FS, Risk Assessments, IQ/OQ/PQ, 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 across the lifecycle.
• Support change controls, deviations, CAPAs, and periodic reviews.
• Maintain validation records within electronic document management systems.
• Participate in internal audits and regulatory inspections.

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.