Sri Ch
- Role
- Equipment Valdation Engineer at Bristol Myers Squibb
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Sri Ch
9 + Experience in manufacturing Equipment Qualification, Process Validation and…
Experience
Equipment Valdation Engineer
Nov 2019 — Present
Develops qualification protocols, and associated reports while adhering to a change management process. •Supports the execution of equipment qualifications and validation protocols. •Supervises vendors for qualification functions. •Develops written procedures for calibration and preventive maintenance of equipment •Supports calibration, equipment qualification and validation activities. •Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. •Supports laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. •Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates. •Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Company’s standards. •Ensured compliance of Electronic Records and Electronic Signatures in compliance with 21 CFR Part 11. •Prepared Validation Summary Report following Qualifications of company standards. •Assisted in development, review and approval of process and equipment validation/qualifications (IQs, OQs). •Maintained Requirements Traceability Matrix (RTM) to track requirements. •Commissioning, Qualification and Validation of 35 (300-liter, insulated) new portable vessels. •Drafted Commissioning Test Pack (CTP)/ Installation and Operational Qualification (IOQ) Checklists. •Drafted and executed Cleaning-In-Place (CIP) verifications. •Prepared, executed, and documented Design Qualification (DQ) protocol and final report of the vessels •Involved in qualifying Utility systems like C02, Compressed and Processed Air in Biologics facility. •Involved in new O2 Manifold installation project in GMP Facilities and BEMS Alarms & RENO Notification testing\'s.
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