Overview In this role you lead validation for GxP-regulated computerized systems, guiding strategy and ensuring regulatory compliance. You collaborate with IT, QA, Engineering, and business teams to validate systems like LIMS, MES, ERP, and laboratory applications. You shape risk-based validation approaches and data integrity practices across the system lifecycle. The position offers influence on validation standards, audits, and continuous process improvements. You will leverage SME expertise to support deployments, upgrades, decommissioning, and regulatory inspections.
Responsibilities- Lead CSV activities for GxP-regulated systems
- Develop and review validation deliverables (plans, URS, FS, DS, IQ/OQ/PQ, reports)
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
- Define and implement risk-based validation strategies
- Validate systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems
- Support system implementations, upgrades, and decommissioning from a validation perspective
- Collaborate with IT, QA, Engineering, and business stakeholders
- Lead change control assessments and assess validation impact of changes
- Ensure ALCOA+ data integrity across validated systems
- Support audits and regulatory inspections with validation documentation
- Mentor junior CSV engineers and validation team members
- Drive continuous improvement of validation processes, templates, and standards
- Review vendor documentation to ensure regulatory readiness prior to deployment
Key requirements- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
- 5-10+ years of CSV or validation engineering experience
- Experience in GxP-regulated pharmaceutical, biotech, or medical device environments
- Hands-on validation of LIMS, MES, ERP, or laboratory systems
- Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5
- Experience authoring and executing IQ/OQ/PQ protocols and validation docs
- Understanding of risk-based validation and data integrity principles
- Experience supporting regulatory audits and inspections
- strong leadership
- excellent communication
- stakeholder management
- CSV (Computer System Validation)
- GxP-regulated environments
- LIMS, MES, ERP, laboratory systems validation
