Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
8-12+ years of relevant Computer System Validation experience in regulated industries.
Deep understanding of GxP regulations and computerized system validation processes.
Proven expertise in validating a diverse range of enterprise systems including LIMS, MES, ERP (SAP), and more.
Strong skills in risk assessments and validation documentation.
Responsibilities
Lead comprehensive Computer System Validation (CSV) activities for GxP systems.
Develop and review essential validation documentation including plans and protocols.
Execute and oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
Ensure compliance with relevant regulatory standards like 21 CFR Part 11 and GAMP 5.
Perform in-depth risk assessments adhering to GAMP 5 methodology.
Manage deviations, corrective actions, and change controls effectively.
Coordinate advanced validation activities across multiple departments and support audits.
Benefits
Opportunity to work in a highly regulated and critical industry.
Chance to lead a team and mentor junior engineers in CSV practices.
Involvement in diverse projects across multiple systems and departments.
Exposure to global regulatory environments and compliance activities.
Full Job Description
Job Description: We are seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for computerized systems used in regulated GxP environments. The ideal candidate will have extensive experience in CSV lifecycle management, FDA and global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements. Responsibilities:
Lead end-to-end Computer System Validation (CSV) activities for GxP computerized systems.
Develop and review Validation Plans, Validation Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
Execute and oversee IQ, OQ, and PQ activities.
Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, and other global regulatory requirements.
Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
Perform risk assessments using GAMP 5 methodology.
Manage deviations, CAPAs, change controls, and periodic reviews.
Support software implementation, upgrades, migrations, and decommissioning projects.
Coordinate validation activities with IT, Quality Assurance, Engineering, Manufacturing, and Business teams.
Support internal audits, customer audits, and regulatory inspections.
Mentor junior CSV engineers and provide technical guidance.
Maintain validation lifecycle documentation according to company SOPs.
Requirements:
Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
8-12+ years of Computer System Validation experience in the pharmaceutical, biotechnology, medical device, or life sciences industry.
Strong understanding of GxP regulations and computerized system validation.
