Sameep Dalal

Engineering Consultant @Pharmeng Technology

Toronto, ON, CA

Drafted, executed, and approved test documentation and Validation Master Plans (VMPs) in collaboration with client leads, user operations, SMEs, responsible engineers, CSV partners, construction QA, automation, electrical, instrumentation, site engineering, and vendors.• Executed commissioning test protocols for egg incubators, cooling boxes, refrigerators, and tanks in coordination with operations and automation teams.• Performed Installation, Operational, and Performance Qualification (IOPQ) protocols on upstream and downstream equipment—including bioreactors, autoclaves/sterilizers, isolators, process skid SIPs, biowaste systems, TCUs, AHUs—and supported facility qualification activities.• Assisted with P & ID walkdowns, process change evaluations, and protocol development.• Identified, initiated, and closed deviations, investigations, and CAPAs using client-approved software, with hands-on experience in Kneat, KAYE Validator, and data loggers for IOPQ execution.• Provided on-site support for Change Control Requests (CCRs), Standard Operating Procedures (SOPs), and Standard Work Instructions (SWIs).• Reviewed executed documentation including FATs, VTODs, CTODs, vendor SATs, VTPs, IQ/OQ/PQ protocols, and feasibility studies.• Facilitated multidisciplinary meetings with CQV, operations, engineering, technical services, and quality teams to ensure compliance with quality standards and coordinated sampling and testing to meet project timelines.