Manufacturing Operation for the Rocky Mount Facility; Supported and implemented necessary cGMP changes across the RM site and primarily SVP Business Unit.Key Projects: Implemented New Captive Gowning ProcessImplemented New Area Control Rings around SVP Classified AreaSupported Critical Manufacturing Line Restarts to maintain Drug Shortage ConcernsLead a 46 cGMP Project Initiative

Process Engineering for the Rocky Mount Facility; Managed an exempt staff of 6 Senior /Associate Process Engineers and a staff of 14 Process Technicians supporting day to day plant support for the R1 and R2 SVP, VisIV, Partfill, SRB and Flex business units. Responsible for process development and design for existing and new processes as related to New Product configurations, Equipment and Line integration. Responsible for management of specific remediation activities from recent MHRA,TGA, and internal audits citing closer alignment to Annex 1 (EU) and PICs requirements. Managed major compliance investigations associated with Line 103 and Line 159 which included assessing product impact, process corrections, and project restart timelines.Recently worked with Industry experts regarding a long standing issue regarding VHP Concentration Monitoring which required process and equipment changes to better control of Environmental Conditioning inside of the R2 Isolator. Process also required DOE testing, RH and Temperature Analysis to provide further definition into indirect factors causing intermittent BI positives.Managed a team to complete 5 remaining Visual Inspection Risk Assessments and determine necessary mitigations to allow continued manufacturing of products identified on the FDA Drug Shortage.

Process/Validation Engineering for the Rocky Mount Facility; Managed an exempt staff of 6 Senior Process/Validation Engineers and a staff of 22 Process/Validation Technicians supporting filling, sterilization of intravenous drugs for the SVP, VisIV, Partfill, GAMMA and Flex business units. Responsible for process development and validation activities for the Computer Validation, Utilities/Facilities and Gamma Irradiation for the RM Facility.Managed multiple project budgets totaling $4.2MM and a spending budget of approximately $1.5MM annually.Scope, price and manage Process and Validation Engineering projects for New Product Introductions, Capital Project Initiatives, Manufacturing Support and Process Improvements.Assure that the manufacturing equipment remains in a cGMP compliant condition and that all validations/qualification are compliant to the current corporate requirements.Conducted presentations of Rocky Mount Validation Programs and the related qualifications listed above during regulatory (FDA, MHRA, EU) and numerous third party inspections.Managed the Validation activities and method development surrounding the Visual Inspection Task force for the Rocky Mount facility.Worked closely with Industry experts and Corporate Quality to develop a corporate procedure for Visual Inspection. Responsible for the qualification, validation and startup of ISO 5, 7, and 8 Class Cleanrooms in addition to the support of implementation of Annex 1(EU) compliance. Responsible for the investigation and closure of all non-conformances (NCR, CAPA) utilizing root cause analysis and problem solving methodologies.Successfully managed the Process Development and Equipment Qualification for the introduction for a H1N1 Antigen. This project was a new venture and required a 3 month introduction schedule for process development, qualification, and trial run testing.

Small Volume Parental Filling and Finishing for the Rocky Mount Facility; Provided Process Engineering Support for SVP TS/Aseptic Filling and Finishing Manufacturing Operations.Supported the implementation of 17 Capital Projects for the Filling and Finishing areas during 2005-2007.Core team member in the implementation of Six Sigma Initiatives Provide Engineering/Validation support to Plant Cost Reduction Teams in key cost reductions/cost avoidances for the SVP Business Unit.Participated in Corporate, Third Party, and FDA audits in support of qualification documentation for validated filling and finishing processes resulting in no 483 citations or complaints.Managed the completion of Process Validations in support of Validation Engineering Yearly Goals and Plant Initiatives.Leader of the Process and Validation Engineering Empowerment Team to improve the TEAM approach and overall department morale following a year of high turnover.

Cleaning Validation and Isolation Technology for the Rocky Mount Facility; Development of new Cleaning Validation Program for a multi-product drug formulation pharmaceutical facility.Development of the Cleaning Validation Master Plan that documents the Rocky Mount cleaning validation program and schedule for assessment and remediation.Implementation of various Capital Projects that enhanced the CIP cleaning process.Assisted in 2004 Budget development process.Directed the SIP/CIP Cleaning Validation Protocol Development.Responsible for controlling budget for Capital Projects related to Cleaning Remediation.Responsible for process development for the SIP/CIP systems for (2) two Isolator Solution Delivery Systems.Responsible for the management of IQ, OQ qualification on the Ampoule Isolator project. (Technologies utilized: VHP sterilization, AMASS sampling, MTC VHP sterilization, SIP sterilization, and CIP cleaning processes.

Experienced in multiple facets of the TS filling and sterilization process including: Product contact equipment cleanability, Washing, Filling, Capping, and Sterilization Technology.Conducted Factory Acceptance testing for all applications listed above.Established Engineering Developmental Studies prior to entering into QualificationAided Maintenance in the trouble shooting of mechanical issues as related to Process shifts.Product Justifications for Sterilization and Filling processes.

Contracted by Abbott Laboratories to conduct and develop Cleaning Validation Testing protocols for the R1 and R2 Facilities.