CSV/CSA Validation Engineer

Role & responsibilities

Required Skills and Experience

• Strong hands-on experience in CSV and CSA activities for GxP-regulated computerized systems.
• Good understanding of regulatory requirements including GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, and validation lifecycle expectations.
• Experience in validation documentation preparation, review, execution, and approval.
• Strong RIM business process knowledge, preferably across regulatory submissions, registrations, correspondence, commitments, publishing, tracking, and dossier management.
• Experience supporting RIM system implementation, upgrade, enhancement, or migration projects.
• Hands-on experience in data migration validation, including source-to-target mapping, migration testing, reconciliation, and defect management.
• Experience with SAP integration validation or validation of system interfaces between enterprise applications.
• Ability to understand business requirements, system configuration, workflows, data flows, and compliance impact.
• Strong knowledge of audit trail, electronic signature, access control, security, and data integrity validation requirements.
• Excellent documentation, analytical, communication, and stakeholder management skills.

Education and Qualifications

• Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, Information Technology, Engineering, or a related discipline.
• Relevant experience in healthcare, pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
• Certification or training in CSV, CSA, GAMP 5, data integrity, or regulatory compliance will be an added advantage.