Responsible for leading Packaging, Engineering and Validation projects and communicating with client and appropriate Project Team members to ensure regulatory compliance and to establish expectations regarding the development, execution, and final reporting of controlled documentation. Responsible for the integration and installation of filling and packaging lines including coordination of OEMs, communication with vendors and clients to assure project expectations are met or exceeded, performing or leading Factory and Site acceptance testing, integration, commissioning and validation. Also responsible for areas of project engagement including client relationships, business development, project status updates, monthly financial reports, and quoting/estimating.

Developed Life Cycle Documentation and executed validation protocols for various equipment and systems.Assisted in the development of validation protocols for enhancements to an existing INOX dryer / Distributed Control System (DCS). System upgrades included operational, data handling and storage capabilities, reporting and security features utilizing a lifecycle approach for this Delta V DCS system upgrade.Performed temperature mapping and executed an Installation and Operational Qualification (IOQ) on a Getinge Terminal Sterilizer (Autoclave) using Kaye Validator 2000s for data acquisition. Also, executed Performance Qualifications (PQs) for assorted vial sizes and load configurations in the autoclave and provided assistance with execution of PQ for formulation vessels.

Developed the Validation Project Plan (VPP) and Software Configuration Management Plan (SCMP) in support of a new facility Supervisory Control and Data Acquisition (SCADA) system that utilized Intellution's iFix, Specter Instruments WIN911, Seagate's Crystal Reports, and Oracle software on a MS Windows 2000 platform. Developed the DDS and Traceability Matrix for this system following GAMP System Life Cycle Development methodology.Produced the Life Cycle Documentation for Mercury Interactive's 'TestDirector' and 'WinRunner for SAP R/3' software packages to provide a complete validated tool for regression testing of SAP R/3.

Developed the Life Cycle Documentation and SOPs for GSK’s LABC21 LIMS (Innaphase PeakPro and LabManager) and Beckman (Innaphase) CHROMLink C/S Analog Interfaces linked to HPLCs and Gas Chromatographs providing data to the LABC21 system. Developed the Life Cycle Documntation and SOPs for a bar code and label design software implementation project.Developed and executed Validation protocols for the facility’s internal security system, building maintenance management software program (MAXIMO), printers and various other peripherals.

Provided system integration services for multiple vendors’ equipment and instrumentation. Conceptualized, designed, manufactured and installed custom fluid process control systems for specialized applications such as batch control, multi-product blending and remote data acquisition systems. Performed repair and calibration for flow sensors and instrumentation. Other tasks included business development, estimating, accounting, inventory management, and logistics.Provided technical and sales assistance to customers (OEMs, distributors, contractors, engineers and end users) in the proper selection and application of flow meters, instrumentation and other process control equipment. Industries served included: Pharmaceutical, Food & Beverage, Chemical, Petroleum, Petrochemical, Municipal, Environmental and Construction.

Conducted engineering analyses in the areas of computational fluid dynamics, thermodynamics, heat/mass transfer, and flight mechanics. Simulated transonic, supersonic and hypersonic aero thermal predictions by programming and/or modifying existing computer codes and compared results with flight and wind tunnel data, and test data obtained via other prediction models. Other contract support functions included: data analyses, code documentation, graphics and database maintenance. Gained extensive experience programming/debugging FORTRAN 77 and a solid knowledge of various computer systems, command languages, operating platforms and utilities.