Bachelor's or Master's degree in a relevant field such as Computer Science, Information Technology, or Life Sciences.
8-12+ years of Computer System Validation experience in regulated industries.
Strong understanding of GxP regulations and validation processes.
Proven track record in validating various enterprise systems including LIMS, MES, and ERP (SAP).
Extensive knowledge of risk assessments and GAMP 5 methodology.
Responsibilities
Lead end-to-end Computer System Validation (CSV) for GxP computerized systems.
Develop and review key 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 such as 21 CFR Part 11 and GAMP 5.
Review user and design specifications to ensure alignment with validation requirements.
Perform risk assessments utilizing GAMP 5 methodology for project scope.
Manage deviations and corrective actions, coordinating with cross-functional teams.
Benefits
Collaborative and supportive work environment.
Opportunities for professional development and mentoring.
Involvement in high-impact projects within the pharmaceutical and biotechnology sectors.
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.
