CSV-GXP with AI ML - Deloitte

Qualifications & 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

Preferred (Nice to Have)

• 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).

Additionally, eLearning Platform Support: Hands-on experience with eLearning platforms; Understanding of typical patterns and challenges in building and sustaining these platforms from a project management perspective