Start Up, Commissioning & validation (Includes plans and protocols generation, execution, troubleshooting, investigations, technical reports, final reports)
Managing of startup of the utilities and process area for the new Parenteral facility at RTP.
Develop of commissioning and start up plans for clean utilities and plant utilities. (pre-treatment, reverse osmosis, multi-effect distillation, CDI/EDI, storage vessels and loop distribution)
Develop of commissioning and start up plans for process equipment such as autoclaves, parts washers, vessels, isolators, Freeze dryers, etc.
Develop of cleaning validation protocols process equipment such as parts washers, vessels, isolators, tanks, bioreactors.
Develop and execution of validation protocols on the process and utilities areas.
