CSV-GXP Professional with AI ML knowledge

Role Senior Software Engineer / Lead Requrement Computer System Validation (CSV) Consultant Experience 3 - 7 years Location Hyderabad / Bangalore / Chennai / Pune Work Mode Hybrid (2 / 3 days WFO) Shift Timing General (11 AM to 8 PM) Key Responsibilites - Execute Computer System Validation (CSV) activities for GxP applications, laboratory systems, manufacturing systems, and enterprise platforms.
- Develop and review validation documentation including: Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications, Design Specifications, Test Scripts (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
- Ensure compliance with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q7/Q10) and company SOPs.
- Collaborate with cross-functional teams (QA, IT, Manufacturing, R&D, and Business Units) to ensure timely validation delivery.
- Perform risk-based assessments to prioritize validation testing.
- Provide audit support for regulatory inspections and internal quality audits.
- Train project teams on CSV processes, documentation standards, and compliance requirements.
- Participate in data integrity assessments and remediation projects.
- Support continuous improvement of CSV procedures, templates, and best practices. Required Skills - Bachelor s or Master s degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.
- 3-8+ years of experience in Computer System Validation within GxP-regulated industries (pharma, biotech, medical devices).
- Strong knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
- Experience validating Laboratory systems (e.g., LIMS, CDS, ELN), Manufacturing systems (e.g., MES, SCADA, PLCs), ERP (SAP), or Cloud-based systems.
- Hands-on experience with risk-based validation approaches.
- Excellent documentation, analytical, and communication skills.
- Understands validation needs for AI/ML-enabled systems, including intended use, data quality, explainability, drift monitoring, human oversight, and revalidation triggers.
- Understanding of PV processes, system workflows, regulatory expectations, documentation and support for validation lifecycle activities Good to Have Skills - Experience with cloud/SaaS validation (AWS, Azure, Veeva, etc.).
- Experience with Testing Tools like Jeera, qTest and ALM
- Knowledge of Agile / SDLC methodologies and their application in CSV.
- Prior involvement in regulatory inspections and client audits.
- Familiarity with 21 CFR Part 820 (Medical Devices) and ISO standards (ISO 13485, ISO 14971).

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