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GENENCOR INTERNATIONAL, a Danisco Company (formerly Eastman Kodak), Rochester, NY 1976–2004
Diversified biotechnology firm with $410 million in annual revenues. International manufacturer of industrial enzymes and other bio-chemicals. Discover, develop, and sell biocatalysts within industrial, consumer, and agri-processing markets. Additionally, serve healthcare market in creating drug development platforms in targeted bio-therapeutics for cancer.
Senior Applications Analyst (1998–2004)
Directed and performed corporate-level application development, support, and maintenance for supply chain, manufacturing, quality assurance, and finance organizations. Managed and optimized effectiveness of and provided user support for Lotus Notes and Domino, Oracle Database, MAXIMO Computerized Maintenance Management System (CMMS), and Siemens Unilab Laboratory Information Management System (LIMS). Ensured compliance with 21 CFR Part 11 and Sarbanes-Oxley (SOX). Point of contact for GAMP4, cGMP, and system validation.
- Led development efforts in designing Lotus Notes application and document change management process for IT systems. Implementation resulted in compliance with Sarbanes-Oxley Act. Rated as "best auditing system" by Price Waterhouse Coopers.
- Directed Y2K compliance project for all embedded systems in company’s process equipment in preventing potential disruptions to manufacturing operations of $200–$300 million company.
- Designed and built application to manage and collect electronic approval signatures and reduced approval and followup time for process manufacturing events by 50%. Implementation of initiative also eliminated one-week turnaround time for obtaining copies of prior product events, now available in electronic form 24/7, and enabled product analyses never previously attempted.
- Remedied problematic event logging and corrective action reporting by overseeing maintenance and development of computerized event logging system started by external contractor. Additionally, worked with plant ISO 9000 teams to further optimize processes and address concerns submitted by external auditors.
- Increased effectiveness and efficiency of corporate operations by architecting and building 40+ custom Lotus Notes applications initiated in response to personal proactive proposals and requests from business areas.
- Conceived, developed, and implemented Corporate QA and Regulatory Processes designed to provide means for effectively storing and retrieving product formations within LIMS system. Achieved improved workflow optimization through eliminating manual record keeping and previous frequent short notice.
Senior Engineer (1986–1997)
Oversaw and performed process engineering studies for site and company management. Served as process control engineer for distributed control system (DCS) at Lexington Avenue plant. Worked closely and effectively with operations and maintenance in troubleshooting processes and equipment. Provided onsite computer support for operations, engineering, and site management. Managed and supported statistical analysis tools, including modeling, statistics, ANOVA, statistical process control, design of experiments (DOE), and graphics.
- Ensured successful ramp up of $15 million facility during commissioning of distributed control system. Worked closely with vendor to correct system bugs in beta test software and with operations personnel to correct programming errors.
- Saved up to 100 labor hours per project and promoted process standardization throughout company. Instrumental in producing "agitation scale-up and analysis kit" used by fermentation engineer as standardized starting point for analyzing processes.
- Designed and implemented unique control algorithm to provide mission critical capability for feeding sugar solutions at very low flow rates to small scale fermentations. Implementation of initiative saved company $1–$4 million, including depreciation effects from requiring additional equipment.
- Key player in preventing operational disruptions when facility was required to vacate former parent company’s computer systems under very aggressive timeframe. Managed project initiatives and implemented necessary systems to migrate applications and process data. Recognized for performance in meeting tight deadlines and producing improved replacement system.
- Successful in building and introducing benefits of process modeling for manufacturing plant in Finland using process modeling software (Gensym G2 with BDS). Information gained and subsequent modeling with BioPro Designer resulted in 50% increase in plant capacity.
- Saved process engineering several hours per week and provided numerous benefits of having standard method of analysis. Architected and deployed sets of standardized process data visualization graphs for SAS/Graph, which ultimately helped engineers and scientists improve technical performance of processes.
PREVIOUS ENGINEERING EXPERIENCE:
Research Engineer (1983–1985)
Investigated parameters affecting production of amino acids via aerobic fermentation utilizing chemical engineering principles and practices. Served on design team of Lexington Avenue green field development facility to ensure suitability of facility to goals and tasks. Designed and executed experiments to establish quantitative impact of off-gas composition on rate of production for particular amino acid.
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