Talented professional with more than 20 years in the biotech field and medical devices. Extensive experience in manufacturing particularly all aspects of Lean practices and Continuous Improvement. Proven performance in process development. Strong familiarity with cGMP practices and parenteral validation, component preparation, formulation and filling. Experience writing deviation reports and working with QA issues.Core Qualifications • Experienced Manager of Component Prep team: managed, trained, and coached manufacturing staff• Expertise in Lean Manufacturing Yellow belt certified, LSSGB in process(6S, Kaizen, Six boxes, Gemba walk, 5Whys)• Skilled in Werum ERP system transactions for manufacturing areas(SAP) and Electronic Batch Record (EBR): execution, review & approval• Proficient in Aseptic Sample collection (GLP) and chain of custody in LIMS sample manager• SME in Ultrasonic machine (Crest), Parts Washer (Reliance 680),Autoclave (Finn Aqua) & Palltronic machine Pre and Post filter test,loads validation using Process Control System (PCS)• Experienced in Pharmaceutical MFG practices and principles (FDAGMP’s, SOP’s & OSHA) • Knowledge of waste water plant treatment and solid waste managementAchievementsUtilized DMAIC model to eliminate down time, NCs, over processing and rework. Process waste was eliminated by 85% with an estimated annual savings of $1.9 million. Parts Washer loads optimization. Wheel for process planning Plan-Do-Check-Act model, process time was reduced by 60% saving electricity, WFI, workers labor and time, representing an annual gain of $3 million. Manufacturing gowning replenishment improvement, reusable scrubs, coverall and booties. Utilized the DMAIC model to change gowning order with specific number for each size. Expenses were reduced by 45%, resulting in an annual cost reduction of over $2.4 million. Received multiple awards and bonuses for continuous improvement, efficiency, and optimization.