IT System CSV Engineer
Role Overview: The IT System CSV Engineer will be responsible for ensuring that computerized systems used within the organization comply with regulatory requirements and internal quality standards.
This role involves developing, writing, and executing Computer System Validation (CSV) protocols, managing documentation, and supporting audits to maintain compliance with Gx P and other applicable regulations.
Key Responsibilities
Develop and author CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Execute validation protocols and document results in accordance with company SOPs and regulatory guidelines.
Perform risk assessments and impact analyses for computerized systems.
Ensure compliance with FDA, EMA, and GAMP 5 guidelines for system validation.
Collaborate with IT, Quality, and business stakeholders to ensure systems meet user requirements and compliance standards.
Maintain validation documentation and ensure traceability throughout the system lifecycle.
Support internal and external audits by providing validation evidence and responding to queries.
Troubleshoot validation issues and propose corrective actions.
Participate in change control processes for validated systems.
Key Requirements
Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.
Experience: Minimum 3+ years in Computer System Validation within a regulated environment (pharmaceutical, biotech, or medical devices preferred) and hands‑on experience writing and executing validation protocols (IQ/OQ/PQ).
Technical Skills: Strong understanding of GAMP 5, 21 CFR Part 11, and Annex 11 compliance requirements; familiarity with ERP, LIMS, MES, or other Gx P systems.
Soft Skills: Excellent documentation and communication skills; strong attention to detail and ability to work under strict timelines.
Seniority Level: Associate
Employment Type: Contract
Job Function: Consulting
Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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