CSV/CSA Validation Engineer

Cloudxtreme; Pune District, Bengaluru, Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Cloudxtreme in Pune, Maharashtra is seeking a CSV/CSA validation specialist to support GxP-regulated computerized systems. You will ensure compliance with data integrity, audit trails, electronic signatures, and validation lifecycle expectations while coordinating with QA and IT teams.

The role requires hands-on validation, documentation, and stakeholder management skills, with experience across regulatory submissions, system interfaces, and data migration validation.

Qualifications

• Hands-on CSV/CSA validation for regulated systems is required.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity.
• Experience preparing and approving validation documentation.
• Strong RIM workflow and regulatory submissions experience.
• Experience with system interfaces and SAP integration validation.
• Ability to map business requirements to system configurations and controls.

Skills

CSV/CSA GxP

Regulatory knowledge

Validation documentation

RIM processes

Data migration testing

SAP integration validation

Audit trail & data integrity

Documentation & communication

Requirements analysis

Education

Bachelor's/Master's in Life Sciences/Pharma/CS/Engineering

Experience in regulated life sciences environments

CSV/CSA/GAMP5 certification

Job description

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.