CHARLES T. FOSTER
CAREER SUMMARY
Engineering professional with 20+ years domestic and international manufacturing and GMP regulatory experience. Successful fulfillment of roles that include facility and equipment design, commissioning, validation, automation systems design, and process support, with major industry leading companies such as Johnson &Johnson, Pfizer, and Biotest Pharmaceuticals. Demonstrated ability in defining and achieving requirements, identifying and resolving technical issues, and deploying design and business objectives in an expedient and cost effective manner. Team oriented with proven results in managing multiple technical projects and personnel.
PROFESSIONAL EXPERIENCE
Biotest Pharmaceuticals, Inc. February 2013 to Present
Product development and pharmaceutical manufacturing company with annual revenue of over $500 Million.
Manager of Engineering and Automation, Boca Raton, Florida
Manage personnel, projects, contracts, and budgeting for Automation, Electrical, and Metrology departments. Responsibilities include collaboration with manufacturing and engineering teams for process issues resolutions and yield improvements. In addition, duties include developing and maintaining an operational budget over $ 2.0 MM, providing oversight on facility upgrades, manufacturing equipment improvements, maintaining site utilities electrical and automation systems, electrical contractor safety, and ensuring compliance to cGMP, FDA, OSHA, NFPA, and NIH/CDC requirements for the Boca Raton site.
• Worked in conjunction with fractionation manufacturing to successfully maintain 6 batches per week from an initial 3 batches per week of Bivigam/NABI product, thus enabling company to meet strategic production goals.
• Supervised the activities of internal and external resources to implement, test, and validate all automation equipment and engineering/system upgrades within established timelines; all activities were completed on time and on budget.
• Developed and implemented a site master plan to upgrade and standardize all high voltage electrical equipment within facility to ensure 24 x 7 site operation.
• Coordinated activities to ramp up production of a cell growth manufacturing facility from four batches per year to over 16 batches per year by the end of 2015 thus supporting overall corporate financial goals.
• Worked in team environment to provide engineering design, capital planning, and oversight for new product expansion; the new facility is planned to be built and commissioned by the later part of 2015, and will support corporate growth strategy.
• Participated in site audit review by various agencies such as FDA, IREC, and Canadian Health Board, and was responsible for successful management of any discrepancies.
• Currently involved in planning, scheduling, and implementation of remediation activities regarding FDA 483 letter; all projects are on track and in line with the overall corporate schedule.
FMT (Facility Management Technologies, Inc.) September 2012 to January 2013
Engineering and Facility Management, based in Cincinnati, Ohio with 0ver 300 employees deployed throughout USA.
Sr. Manager of Operations, Greater Memphis TN Area
Supervised office, contracts, budgets, personnel, and projects for Memphis area engineering office. In addition, provided engineering and facility management activities for diverse industry customer base in the Greater Memphis area as, well as throughout the southeastern USA. Responsibilities included developing and maintaining an operational budget, oversight and full closure on all technical projects, enhancing customer base, and maintaining full compliance to state and federal regulations.
• Managed the startup of a new regional office in the Memphis, TN area on time and within budget.
• Developed FDA test protocol to successfully validate new product freezers in Memphis area pharmaceutical facility.
• Implemented plan to upgrade Memphis J&J facility for the purpose of increasing operational efficiency for the picking and packaging lines.
PFIZER, INC. 2001 to August 2012
Research based and global operations pharmaceutical company with annual revenue of over $48 Billion.
Manager, Fac. and Engineering (Pfizer), Memphis, TN (2007 to Aug 2012)
Manage contracts, budgets, personnel, automation, and engineering activities to ensure proper compliance and operational support for Pfizer’s largest logistics center, located in Memphis, TN. Responsibilities include developing and maintaining an operational budget over $ 850,000, providing capital input and oversight on all facility improvements, TPM and predictive maintenance scheduling, and ensuring compliance to cGMP, FDA, DEA, OSHA, NFPA, and TSA requirements for all Pfizer sites.
• Supervise contractors and a facility staff responsible for repair and preventative maintenance of all HVAC units, automated (PLC) conveyor systems, camera tracking system, lighting throughout the facility, building maintenance, cooling units, material handling equipment, fire monitoring system, calibration, and documentation for all site operations.
• Led the design, installation, and successful validation of a 5000 sq. ft. cooler and freezer, and automated packaging line used for a new cold chain product launch. The $1.2 MM project was delivered on time and below budget.
• Coordinated the design, installation, and commissioning of a Honeywell BMS (Building Management System) used to control the warehouse and office HVAC system. The new system has consistently provided > 10% savings annually on HVAC costs.
• Participated in a team environment with the Pfizer Logistics LEAN team to define new order fulfillment processes and metrics, establish budgets and requirements for the re-structuring of the facility and packaging lines that led to an annual savings of over $1 MM.
Manager, Electrical Engineering (Pfizer), Ann Arbor, MI (2003 to 2007)
Responsible for Electrical and Controls systems for the Ann Arbor and Kalamazoo sites, including approximately 35 buildings and over 2 million square feet of pharmaceutical research and clinical manufacturing facilities. Provide technical management and oversight of system designs, specifications, standards, commissioning, validation, and regulatory compliance to cGMP, FDA, AALAC, and NFPA standards for all site systems.
• Designed, installed, and commissioned various projects such as a site electrical distribution system, HVAC controls for site facilities, and Building Automation Systems for large capital building projects ranging from $5 MM to $70 MM that provided for efficient and timely R&D activities.
• Upgraded and validated Critical Environmental Systems for animal vivarium monitoring, animal drinking water systems, and Building Automation System (BAS) to Supervisory Control and Data Acquisition (SCADA and PLC) regulatory compliant systems resulting in 100% compliance of regulatory requirements.
Senior Process Automation Eng...
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