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).
Solid 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

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