Generated and executed validation protocols for freezer(s) temperature studies and a hazardous storage area.Worked on developing and executing RDs, DTs, IQs, OQs, and ACOs for site-wide building monitoring system (BMS) upgrade project.

Performed validation and engineering activities in 3 biopharmaceutical facilities - mammalian/microbial, plasma, and aseptic filling. Developed and executed automation, cleaning, process, equipment validation, and commissioning protocols. Trained and mentored (7) internal employees in validation, engineering, and technical writing. Knowledgeable with cGMP, FDA CFRs, OSHA standards and regulations, and Lock-out Tag-out procedures.

Involved in developing commissioning and IOQ documents for aseptic renovation project.Developed and executed HEPA cart commissioning and IOQ documents.Generated/edited final reports.Validated aseptic fillers, cappers, sealers, vial washers, lyophilizers, and raised stopper detection systems.

Involved in developing and executing 30 IOQ documents for product relocation project.24/7 shift coordination, scheduling, and execution of buffer and product equipment.Led a team of 4 engineers for the validation effort of 8 WFI pumps and HWFI stills. Reviewed pre and post executed automation protocols for site wide turnover project.

Responsible for medical supplies throughout emergency room. Ensured all supply drawers were filled and ready for use.Expedited patient transport.