Coaching teams, building tools and improving processes!

Led directly the Engineering, Facilities, Maintenance, Metrology and Validation departments. Developed long-term and short-term strategies, objectives and plans to support the manufacturing of Biosimilars providing quality clean rooms, equipment , utilities while maintaining current validated state of current processes. Sustain and improve department practices to ensure the production of high quality product. Proposed, budgeted and executed manufacturing expansion and supported the development of new line products.

Analyze current business manufacturing processes and strategies, identify gaps and develop new optimized strategies and upgrade solutions to enhance operations and optimize profit.• Operations efficiency Business Analysis • Help companies reconfigure CMM systems and MRP software that will capture effective KPIs and efficient reliability failure codes that not only will capture reliable data but also reduce repair times.• Commissioning of buildings and equipment.• Solutions for complex engineering and design.• Solutions for lean operations• Reliability Engineering.• Rewrite of SOPs to reflect cGMPs, GLPs, CFRs and other regulatory codes effectively reducing risk during regulatory audits and at the same time improving the efficiency during execution.• Business performance and risk analysis based on multi trends and current company practices.

Ensure effective manufacturing processes of CRYO, Albumin, Factor VIII, Factor IX, Factor IV, and II + II paste. Provide reliable Class 100 to Class 100,000 clean room equipment as well as buildings including clean rooms, HEPAS, HVAC, Differential Pressure Control and utilities such as PW, WFI Hot and Cold, Tower Water, CCA, Clean Steam, and 96% Alcohol Distillation. Identify skill gaps and devise hiring strategies. Ensure safety practices are upheld and OSHA recordables are minimized. Represent organization appropriately in audits from regulatory agencies such as the U.S. FDA and health authorities in other countries. Review and improve SOPs across multiple departments in order to ensure CGMP regulations are met. Implement programs to improve efficiency of maintenance operations including Reliability Engineering, Kaizen events, training, and FMEA and statistical trend analysis. KEY ACCOMPLISHMENTS: Oversaw several department including an Associate Director, managers, and supervisors while meeting and exceeding established objectives. Instrumental in reducing maintenance failures and becoming most efficient Grifols plant through successful management of maintenance operation with seven departments and six buildings within a budget of under $6.25 million annually. Implemented custom program to reduce need of contractors and non-productive time which ultimately cut cost of operations and maintenance by 50% and additionally improved skill levels of technicians, operators, and engineers. Substantially reduced priority one corrective issues from 16% to 3%. Increased equipment reliability and manufacturing process yields from 78% to 99.9%. Contributed to management of $450 million building project for new process of IGIV with complex PLC networks on Wonderware platform and remote stations.

Managed all plant operations and 58 employees including supervisors and managers. Reduced manufacturing costs and increased production as a result of generating and implementing new manufacturing processes while upholding current manufacturing standards. KEY ACCOMPLISHMENTS: Created Windows based applications utilizing C++ code to develop automation of sorting and calculating data through Pro Engineer and GibbsCam increasing manufacturing capacity by 25%. Designed, developed, implemented, and tested cost-effective mechanical devices that increased quality and production while reducing scrap rate to less than 1%. Automated inspection of custom parts and reports by developing VBA code and macros. Automated 2,3,4, and 5 axis machines through development of formulas and equations.

Effectively managed machine shop and 30 employees including supervisors. Created manufacturing processes for new projects, Work Instructions, and Master Work Instructions that met ISO 9002 standards and additionally streamlined production. KEY ACCOMPLISHMENTS: Increased production up to 300% and revenue to over $17 million per year as a result of developing solutions to improve manufacturing time. Independently responsible for resolving 5 year manufacturing conformance issue and saving accounts by testing and implementing 6 Sigma SPC charts using personal customized graphs to track variances in 5 axis machining, while maintaining production rates and not violating CSOPs. Developed detailed setup sheets and instruction documentation for CNC operations, cutting setup time to 30% of time it originally took.