Bachelor's or Master's degree in relevant field (Computer Science, IT, Life Sciences, etc.)
8-12+ years of experience in Computer System Validation within pharma, biotech, or related industries
Deep understanding of GxP regulations and validation processes
Experience with various enterprise systems including LIMS, MES, and ERP (SAP)
Strong skills in risk assessment and validation documentation
Responsibilities
Lead comprehensive Computer System Validation (CSV) efforts for GxP systems
Develop and review critical validation documentation like Plans, Protocols, and Reports
Execute and manage Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
Ensure alignment with regulatory standards (21 CFR Part 11, GAMP 5, etc.)
Review User, Functional, and Design Specifications for compliance
Perform risk assessments in accordance with GAMP 5 methodologies
Oversee deviations, CAPAs, and change controls while coordinating with various departments
Support audits and regulatory inspections to ensure validation integrity
Benefits
Opportunity to mentor junior engineers and contribute to their growth
Collaborative work environment with cross-functional teams
Engagement in high-stakes projects that involve enterprise software implementations
Exposure to regulatory audits and inspections, enhancing professional credibility
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.
