Versatile Process Automation Engineer, highly effective at working independently and as part of a team. Expertise in project planning, management and field implementation.
Process and Controls Engineer January 2008 to CurrentCastle Hill Technologies － Raleigh, NC
Pernambuco Biotech Facility (Novartis Vaccines) Distributed control system (DCS) lead automation engineer.
Design control scheme for facility, including process and utility areas.
Collaborate with multi-discipline team to develop process operations that are efficient and consistently repeatable.
Develop and manage automation documentation library.
Review all automation functional specifications generated by automation team.
Perform equipment testing at vendor facilities.
Pandemic Flu Vaccine Facility Project (Novartis Vaccines) Startup/commissioning of buffer preparation and distribution equipment.
Operational startup tests of CIP systems.
Commissioning/qualification and change management for Filling line equipment.
Providing support from design to qualification for modifications to the Formulation suite for addition of small volume formulation option.
Commissioning/qualification support for Steam-out-of-place system in FF Parts Prep area.
Performing ACR changes and software testing for upstream, downstream and formulation area unit operations.
R&D and Commercial Production Parenteral Formulation and Filling Project (Eisai) Decontamination and Sterile Processing- Developed interface between vendor supplied skid equipment and SCADA system for operating parameter control and data acquisition in compliance with 21 CFR part 11 Compounding Area Production- Developed modular procedural sequencing for use in R&D as well as Commercial Production environment Batch Reporting- Worked with QA and manufacturing client personnel to develop batch reports for manufacturing and utility areas Material Staging and Asset Tracking- Developed and implemented system for tracking genealogy, sterilization and usage of ingredients, equipment and consumable materials Developed and maintained process area documentation that included project modifications in a cGMP compliant manner.
Process and Controls Engineer January 2003 to January 2008The RoviSys Company － Aurora/Apex, OH/NC
Pneumolysin Vaccine Clinical Trials Manufacturing Project (Wyeth) Fermentation Area Production- Developed and operated batch procedures including fermentation, pH control, product transfer between vessels, and harvest Recovery Area Production- Developed, troubleshot and operated batch procedures including centrifugation, depth filtration, and product transfer Purification Area Production- Developed, troubleshot and operated batch procedures including chromatography, ultra-filtration, product dilution and concentration Buffer and Media Production- Created circuit paths to transfer buffer and media to vessels throughout the facility.
Operated buffer preparation and transfer procedures linking them with purification and fermentation processes CIP/SIP- Generated software code, Functional Specification and Detailed Design Specifications.
Operated CIP/SIP cycles for portable equipment, fixed equipment and transfer piping Trained client operating personnel in the operation of the control system and equipment Assisted in calibration and configuration of instruments on bus networks including fieldbus, profibus and devicenet Developed standard operating procedures for control system changes Managed control system software and documentation updates in a cGMP compliant manner Commissioned and validated a batch control system with approximately 7000 I/O Meningitis Vaccine Project (Wyeth) Process Area Development- Managed batch procedure development in a validated environment following S88 batch processing model Developed customer acceptance protocols to be leveraged as validation protocols as well Maintained process area documentation that included Meningitis project modifications in a cGMP compliant manner.
RPB Project II and III (Ross Products Division of Abbott Laboratories Casa Grande, AZ and Columbus, OH) Retort Sterilizer Production- Developed, troubleshot, and performed process improvements to resealable plastic bottle sterilization process line Specified process and control equipment Commissioned, validated, and assisted in calibration of pressure, temperature, flow, and level measurement instrumentation Trained client personnel in the operation sterilization process line.
Advanced Engineering Summer Intern January 2000 to January 2001Molded Fiberglass Premier Molding Company － Ashtabula, OH
Developed an understanding of manufacturing process design and development in a lean manufacturing environment by working closely with advanced engineering department and manufacturing customers Gained Solid Modeling experience Was responsible for 3D profile analysis and quality control of prototype parts Worked extensively with plant engineers, administrators, and hourly personnel Decontamination and Sterile Processing Compounding Process Material Staging and Asset Tracking Fermentation Process Recovery Process Centrifugation Process Sterilization Process Chilled Water, Glycol and Steam Distribution WFI Generation, Storage and Distribution Clean Steam Generation Flat-plate Heat Exchangers RO Water, Storage and Distribution.
DCS: Emerson DeltaV
PLC: Allen Bradley
Database: MS Access 2000, MS SQL Server, OSIsoft PI
Graphics: Designer, AutoCAD, MS Visio Technical 2003