Job-ID Reference Job Summary:The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements.
The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentation, validation execution, and quality governance for enterprise systems such as Veeva Vault, SAP GxP modules, and LIMS platforms.Roles & Responsibilities:Ensure compliance of computerized systems with regulatory standards including 21 CFR Part 11, GxP, GAMP 5, EU Annex 11, ISO 9001, SOX, and ITIL frameworks.Perform audit readiness activities including periodic system reviews, access control evaluations, and audit trail reviews.Manage and execute validation lifecycle documentation including URS, FRS, Validation Plans, Protocols (IQ/OQ/PQ), RTM, and Validation Summary Reports.Support deviation management, CAPA execution, and change control processes in alignment with SOP and quality policies.Apply risk-based validation strategies aligned with CSA (Computer Software Assurance) principles.Provide validation support for enterprise systems such as Veeva Vault suite, SAP GxP modules, Labware LIMS, Biovia ELN, and other regulated platforms.Collaborate with cross-functional teams in Clinical, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Discovery, and Manufacturing domains.Support implementation and validation of RPA GxP bots and AI/ML-based regulatory and manufacturing systems.Ensure quality system compliance through documentation review, SOP adherence, and governance activities.Contribute to validation of data visualization tools and analytics platforms used in regulated environments.Education & Experience:Bachelor's or Master's degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.Experience in Computer System Validation (CSV) within pharmaceutical or life sciences regulated environments.Strong knowledge of GxP regulations, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX compliance requirements.Experience with validation of enterprise systems such as Veeva Vault, SAP GxP modules, LIMS, and electronic quality systems.Familiarity with risk-based validation approaches and CSA (Computer Software Assurance) methodologies.Exposure to validation documentation lifecycle including URS, FRS, IQ/OQ/PQ, RTM, and validation reports.Understanding of audit processes, CAPA management, deviation handling, and change control systems.Knowledge of pharmaceutical domains such as Clinical, Pharmacovigilance, Regulatory Affairs, Manufacturing, and Medical Affairs is preferred.Experience with tools like Veeva Vault, Labware LIMS, SAP, and electronic lab notebooks is an advantage.
CSV Engineer in wilmington at Unknown Company
This position is listed as full time and onsite.