Manufacturing Process Engineer
CurrentLed end-to-end management of the Bausch+Ströbel Variosys system, overseeing equipment setup, qualification, and continuous operation for aseptic filling processes.Conducted process engineering analyses to identify efficiency gaps, optimizing filling, sealing, and packaging processes to reduce cycle times and minimize product loss.Designed and executed process validation protocols (IQ/OQ/PQ) to ensure compliance with FDA, EU GMP, and ISO regulatory standards.Spearheaded equipment maintenance and calibration schedules, collaborating with maintenance teams to prevent downtime and extend equipment life cycles.Played a key role in cross-departmental projects, partnering with R&D, Quality Assurance, and Manufacturing teams to implement process improvements and manage technology transfers.Developed and updated Standard Operating Procedures (SOPs), work instructions, and training materials to ensure adherence to best practices and regulatory standards.Led investigations for process deviations, OOS results, and non-conformances, applying root cause analysis and implementing CAPA (Corrective and Preventive Actions).Supported change control processes and managed process documentation for regulatory submissions, audits, and inspections, ensuring full compliance with cGMP requirements.Provided technical leadership during troubleshooting sessions, diagnosing equipment malfunctions, and implementing effective solutions to maintain operational continuity.Conducted process simulations, modeling, and FMEA (Failure Mode and Effect Analysis) to proactively identify and mitigate process risks.Trained and mentored operators, technicians, and junior engineers on equipment operation, aseptic techniques, and process optimization methodologies.