Job Description
Summary :
As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA CFR Part , EU Annex , and other applicable regulations.
Roles & Responsibilities:
Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports. Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity. Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations. Provide training to stakeholders on validation requirements and best practices. Maintain validation lifecycle documentation and change control records.
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