Satya Pradeep Matta
Validation Engineer | Quality & Process Engineering | Commissioning & Verification | SME in CTUs, Autoclaves, SIP Systems | Driving FDA/ISO Compliance & GMP Excellence in Pharma & Biotech
- Role
- Validation Engineer at AGC Biologics
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Satya Pradeep Matta
Accomplished Validation and Quality Engineer with 4+ years of experience in the…
Experience
Validation Engineer
Jan 2023 — Present · 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.
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