Computer System Validation

Position Overview

We are seeking an Entry-Level Computer System Validation (CSV) Engineer to join our dynamic team supporting critical validation activities within the pharmaceutical and life sciences sectors. This role is pivotal in ensuring the integrity, safety, and compliance of computerized systems used throughout product development and manufacturing.

Key Responsibilities

• Facilitate end-to-end CSV lifecycle documentation for GxP-regulated computerized systems.
• Assist in drafting User Requirement Specifications (URS), conducting risk assessments, and developing validation plans, protocols, and final reports.
• Execute IQ/OQ/PQ testing activities to verify system performance against design specifications.
• Maintain robust traceability matrices and comprehensive validation documentation suites.
• Support organizational change control processes, deviation investigations, and CAPA (Corrective and Preventive Action) initiatives.
• Ensure all systems strictly comply with GMP, GxP guidelines, 21 CFR Part 11 electronic records requirements, and GAMP 5 best practices.
• Collaborate effectively across cross-functional teams including QA, IT, Engineering, Manufacturing, and Business Operations.
• Promote audit readiness by maintaining organized documentation for internal and external regulatory inspections.