CSV Specialist

CSV Specialist

The CSV Specialist will plan, execute, and document validation activities for GxP-regulated computerized systems. This role supports system lifecycle activities, audits, and compliance initiatives while ensuring adherence to FDA CSA guidance, 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles. The ideal candidate is hands-on, documentation-driven, and experienced working independently across multiple regulated systems in pharma, biotech, or medical device environments.

Roles And Responsibilities

• Author and execute CSV deliverables including:
• URS, FS/DS, Validation Plans (VP)
• Risk Assessments (RA)
• IQ / OQ / PQ
• Traceability Matrices
• Validation Summary Reports
• Apply risk-based validation approaches aligned with GAMP 5 and FDA CSA
• Serve as a CSV Subject Matter Expert (SME) during audits and inspections
• Support change control, periodic reviews, and system lifecycle management
• Partner with IT, QA, Operations, and Laboratory teams
• Ensure data integrity compliance per ALCOA+ principles
• Manage multiple validation projects independently in a fast-paced environment

Education And Experience

• Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field
• 5–8 years of experience in CSV / GxP validation
• Minimum 1 year of hands-on experience under FDA CSA
• Experience validating systems such as:
• LIMS, ELN, MES, QMS, CDS
• ERP or clinical systems
• Strong technical writing, documentation, and communication skills
• Proven ability to work independently and manage competing priorities
• GAMP 5 training
• ASQ certifications: CQA, CSQE, CQE
• PMP or Agile certification
• Experience in pharma, biotech, or medical device environments