CAREER PROFILE:

Engineering & Maintenance professional with over twenty years’ experience in operations, maintenance, troubleshooting and repair of pharmaceutical manufacturing equipment & facilities. Cost-conscious, well organized, innovative and practical. Profound knowledge of manufacturing systems, manufacturing process, maintenance, and regulatory requirements (FDA, cGMP, OSHA, and EPA). Experienced in FDA multi-product establishment and inspection process. Contractor and construction sitemanagement.

SKILLS:

Dedicated team leader with well-developed communication skills.

Ability to engineer the startup of new products, equipment and designs.

Ability to deal with high volume pressure, i.e. presently approximately 2K formulas, 60K chemicals and 145 holding tanks which require high interface with all manufacturing employees and upper level management.

Extensive knowledge of manufacturing of Pharmaceutical products.

Detailed knowledge of construction operations

Worked in all aspects of Pharmaceutical related fields. SAP, QA/QC, Supervision, Production Supply specialist, BCR issues, Compounding, Batches, Chemicals, Technical Support

Ability to lead and set example for team concepts and teamwork methods.

Extensive experience with all manufacturing machinery, In-Process testing to support continuous improvements, and all standard and up to date GMP guidelines

Invested team player willing and able to assist any department.

PROFESSIONAL EXPERIENCE:

Glenmark Pharmaceuticals INC, USA (May 2015-present)

Maintenance technician

Responsible for Initial receipt and inspection of new equipment.

Oversaw all contractors at work site while under construction.

Assisted with new equipment installation.

Worked as liaison between contractor management and Glenmark project team to ensure smooth daily operations and security of the site.

Key stakeholder in the IQ/OQ of packaging line, which included all parts verification and tool purchasing for primary and secondary packaging.

Assisted in the installation and IQ/OQ of Purified water skid and flawlessly maintained its operation in the absence of the facilities mechanic.

FUJI FILM/ DIOSYNTH BIOTECHNOLOGY Morrisville, NC (2000-2014) Maintenance Mechanic

Responsibilities include; the operation, maintenance, troubleshooting, and repair of pharmaceutical process equipment. Equipment included but not limited to; Centrifuges, Homogenizers, Bioreactors, Fermenters, Columns and packing stations, Autoclaves, Glasswashers, Pressure vessels and agitators, Clean-in-place skids, Liquid chromatography skids, and Ultra filtration skids. Develop and formulate written instructions for preventive maintenance tasks and SOP’s as necessary. Assist facility coordination with planning equipment/system shutdowns for maintenance. Perform work order and logbook documentation to insure FDA/EMEA compliance. Maintain/order spare parts. Perform changeovers on all equipment as needed.

Work Scope:

Floor support for Engineering runs, media challenges, and Validation runs.

Execute IQ/PQ protocols and close-out documentation.

Assist with equipment troubleshooting as required.

Industrial Engineering (2010-2012)

Implemented procedures, work with Research and Development.

Investigated and implemented CAPA’s.

Extensive experience with hands on use and knowledge of tools required to identify and correct main causes of problems and issues.

7+ years working Six-Sigma. Presently maintain Yellow Belt and was working towards Green Belt Certification.

Senior Purification Associate (2001-2010)

Manufacture of Active Pharmaceutical Ingredients in a GMP environment.

Large Scale Purification of Proteins using Pharmacia Chromatography skids (with UNICORN interface), various types of columns and resins, and Ultra-filtration systems.

Execute manufacturing process documentation, Validation protocols, Experimental Test Procedures, and Standard Operating Procedures

Utilize the Distributed Control System (DCS) for Clean-in-Place, Steam-in-place, and facility water procurement.

Perform Bulk Product fills using Aseptic Technique

Train new operators on use of process equipment

Contract-Processing/Data Entry (2000-2001)

Incorporated spare parts, changeovers, design PM’s and installed new Manufacturing equipment into MP2 computer system,

Checked parts inventory and interface with processing Engineering and Validation group for all new projects.

BRISTOL MYERS SQUIBB - Pharmaceuticals & Clairol

Clairol - Stamford, Connecticut (1997-2000)

Production Supply Specialist (PCS)

Played an essential role in the daily flow of batch making, inventory accuracy and SAP transactions within the processing department.

Key player in implementing and training for the Production Supply Specialist positions in the processing department

Hands on experience with processing and tracing chemicals on SAP computer system.

Supervised Bulk Weight of chemicals and developed new implementations to increase productivity.

Trained inexperienced employees to operate SAP computer system which is an essential role dealing with the processing department in the flow of batch making, inventory accuracy and is a continuous developing position.

Worked in all aspects of Clairol manufacturing including QA, warehouse and process services.

Pharmaceuticals Division - Morrisville, North Carolina (1981-2000)

Technical Support for Processing Bar Code System

Established manufacturing procedures involving new machinery implementations.

Primary Overseer of the transfer and reconstruction of liquids from one state to the other.

Supervisory experience to retesting in pharmaceutical Labs

Oversaw rejected products received from packaging and implemented resolve procedures to have reworked.

Knowledge of manufacturing solid dose formulations.

EDUCATION:

Durham Technical Community College, Durham, North Carolina

Associate in Applied Science - Industrial Management Technology May 1988

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