Payal Tandal

Experience

1. Validation Engineer

   Trinity Consultants - Advent Engineering

   Mar 2023 — Present · CA, US

   Familiarity with Good Manufacturing Practices (GMP) and FDA compliance standards- Working as Validation Engineer 1 for a client company in Marin County- Focuses on cleaning validation including clean-in-place (CIP), steam-in-place (SIP) or sterilization, and manual cleaning procedures- Technical protocol and report writing for cycle development (CD) of new parts, process validation (PV), and revalidation evaluations (RVE)- Timely executes protocols on quarterly basis for initial validation, change requests, and periodic review of the cleaning procedure- Performs Cleaning Verification Sampling for CIP executions: Collects rinse samples such as bioburden, endotoxin, TOC, and conductivity; Determines appropriate swab location(s) on equipment/part and collects swab samples- Sets up equipment with temperature recorders (TR dataloggers) and biological indicators (BIs) to measure the successful elimination of bacterial growth during sterilization- Generates validation discrepancy reports (VDRs) to capture and investigate the root cause for protocol deviations, failed or invalid results and establish an action plan including identifying corrective and preventative actions (CAPAs)- Exposure to Autoclaves, Bioreactors, Buffer Vessels, Chromatography Columns, Diptubes, Fermenters, Flowmeters and Pumps, Skids, Pressure Gauges, Process Hoses, Ultrasonic Baths (USB), Glassware/ Parts Washers.