Satya Pradeep Matta
Validation Engineer @AGC Biologics
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WORK HISTORY
Validation Engineer @AGC Biologics
US
CTU Qualification SME for site‑wide requalification (~175 CTUs across sites).Standardized templates, mapping, and reports per ISPE and Annex 15.• SIP Systems SME (12 months): authored/optimized SIP work instructions, verifiedalarms/interlocks, and ensured reproducible cycles aligned with EN 285 and FDAaseptic guidance.• Planned and executed IQ/OQ/PQ for CTUs, SIP systems, autoclaves, incubators, andbioreactors; authored protocols, reports, and acceptance criteria per SOPs & Annex 15.• Conducted steam quality testing (dryness, superheat, NCG) per EN 285 Annex B andISPE Steam & Water guidelines.• Quality engineering: deviations, CAPAs, change controls, risk assessments (ALCOA, dataintegrity). Maintained audit‑ready documentation for FDA/EMA compliance.• Mentored manufacturing and QA staff on validation tools (Kaye AVS, Ellab ValProbe)and data review practices.
ABOUT SATYA PRADEEP MATTA
Accomplished Validation and Quality Engineer with 4+ years of experience in the…
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