CSV Engineer

CSV Engineer / Validation Engineer

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 and 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 and 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.