(000) 000-0000 (h)
(000) 000-0001 (c)
PROFILE: Operations and engineering professional with over twenty years experience in design, construction, start-up, operation and maintenance of pharmaceutical manufacturing facilities. Cost-conscious, well organized, innovative and practical with sound knowledge of building systems (structural, mechanical, electrical and security),
regulatory requirements (FDA, cGMP, OSHA, EPA, and DEA), and manufacturing operations (dry products manufacturing, packaging . liquid and tablet, and materials management). Skilled in business operations and communications, as well as community relations. Experienced in FDA multi-product establishment and inspection process.
PROFESSIONAL COMPANY, City, STATE (1992-Present)
EXPERIENCE: Plant Manager
Responsible for all production, maintenance, facilities, and materials management for dry products contract manufacturer. Was original employee at facility responsible for startup, hiring, validation, and facility master plan. Manage a staff of 140 (manufacturing 97, maintenance 18, and materials management 25). Responsible for budgeting all three departments. Facility ran 11 million pounds of product last year in a 40,000 square foot facility. Played major role in 60,000 square foot expansion completed in January 1998, having responsibility for management of facilities design, hiring outside engineering firm and architect for $14.5 million expansion for finished dosage forms.
- Successfully trained entire staff of non-pharmaceutical personnel in cGMP and plant operations that resulted in the facility being profitable in first year of operation.
- Plant has passed numerous FDA, DEA, OSHA, and customer audits.
- Contracted, implemented, and validated installation of DI water system.
- Chaired $14 million expansion to accommodate company growth from research to manufacturing, consistently completing work on schedule and within budget with no interruption in manufacturing.
- Increased production to a seven day a week, twenty-four hour cycle from an initial three shift, five day/week operation within first year of start-up.
- Purchased, installed, and validated a catalytic oxidizer. Headed up the permit process with the Kentucky EPA
- Plant won the Kentucky/Tennessee Valley Association Industrial Award for wastewater treatment compliance.
COMPANY, City, STATE (1981-1992)
Responsible for production on a day-to-day basis from an engineering and efficiency
standpoint. Evaluating equipment and personnel for more efficient production and
solving technical problems as they arose. Responsibilities included the coordination of large projects between Engineering, Manufacturing and/or outside contractors with the Production Department. Responsible for capital and operating expenditures.
- Identified and solved equipment malfunctions resulting in improved production in granulation area from 46% to 90% in less than nine months.
- Converted warehouse area into a GMP dry product production area (granulation to tableting). Completed project on time and under budget.
- Acted as General Contractor on a $5 million renovation saving the company
- $500,000. Maintained productivity in manufacturing during construction.
- Served as Project Engineer on a major packaging department renovation. Relocated and redesigned seven packing lines using new and existing equipment in less than one year. Converted these lines to process controlled lines. (3 tableting lines, 4 liquids)
COMPANY, City, STATE (1980-1981)
Responsibilities included piping structure designing for the central engineering refinery section with both existing systems and new constructions. Responsibilities also included package line layout and design.
- Central engineering for multiple facilities nationwide.
- Revamped problem packaging area to increase productivity and reduce maintenance costs.
COMPANY, City, STATE (1979-1980)
Responsibilities included the design of meat and food processing equipment such as
boning tables (steel and rubber belt) and several varieties of conveyors. Designed and issued drawings for production. Coordinated production with shop and assembly
personnel and conducted final inspection before shipment to customers.
COMPANY, City, STATE (1976-1979)
Responsibilities included updating and/or evaluating production lines to improve line
efficiencies. This included interoffice coordination with all departments involved along with supervision of contractors/maintenance personnel to insure timeliness of projects.
EDUCATION: Degree, University, City, STATE
Additional Degree Information
COMPUTER: Lotus 123, Word Perfect, Microsoft Word, Excel