
Detail-oriented formulation technician with expertise in aseptic gowning, GMP compliance, and isolator operations. Instrumental in maintaining audit-ready conditions and training new technicians to uphold high standards in sterile manufacturing.
Prepare sterile bulk formulations through validated closed systems supporting commercial PFS production under cGMP.
Set up, operate, and perform changeovers on Optima isolator syringe and cartridge lines in ISO 5 environments.
Execute line clearance, material accountability, and GMP documentation in compliance with ALCOA+ standards.
Perform filter integrity testing using Palltronic Flowstar IV and ensure full traceability of results.
Partner with QA and Environmental Monitoring teams to maintain audit-ready aseptic conditions.
Maintained zero critical deviations by following stringent quality protocols across all batches.
Train and mentor new technicians in aseptic gowning, isolator setup, and documentation best practices.
Executed formulation and aseptic manufacturing operations according to validated SOPs and cGMP standards.
Reviewed batch record documentation (BR/EBR) to ensure compliance with data integrity initiatives.
Conducted in-process testing including pH, conductivity, and osmolality.
Assisted in troubleshooting equipment and coordinating preventive maintenance to enhance operational reliability.
Maintained daily sanitization protocols within controlled cleanroom environments.
Supported implementation of manufacturing technology to streamline production processes.