• Liaison with Micro Biology (Sterility), CAPA Department, Manufacturing, and Supplier Management to ensure cleaned components and finished product meet the requirements of Zimmer Bioment, and ISO 10993, for CCl4 Extractable, Bacterial Endotoxin Test (BET), Water Extraction, Cytotoxicity Test, Total Organic Carbon (TOC) Analysis, and Particulate/Debris Analysis.• Conducted Internal Investigations of cleaning test failures to determine root cause and determination of CAPA requirement.• Cleaning team representative during CAPA Board Meetings.• Conducted numerous CAPAs releating to cleaning issues including those resulting in field action (Recall).• Authored response to Notified Body for cleaning issue observations.• Co-authored 483 response for cleaning department findings.• Conducted on site vendor audits in support of cleaning department.• Mentor junior team members, on proper investigation techniques, root cause analysis, and conduct of CAPAs.

Working as project manager and as independent contractor provided regulatory compliance consulting services for regulated manufacturing infrastructures. These services include validation services for Process Systems and Equipment, Facilities, Utilities, Automation and Manufacturing Processes in the Pharmaceutical (Finished and Bulk), Medical Device & Diagnostic, Consumer Products, and Veterinary Industries.Manufacturing Process Development and Validation of Class 3 Medical Device.Developed new procedures and rewrote existing procedures to bring processes into ensure product safety, and cGMP compliance.Relied upon by department managers as technical expert and problem solver.Worked directly with Engineering, Production, and Quality departments to streamline and validate manufacturing processes.Software testing for production test systems. Test Method Validation of automated and manual test systems.Developed Test Methods and Workmanship Standards for SMT Processes, Laser Weld Processes, and In-Process AssembliesProgram Manager leading multiple Product Safety Committees for multi-million dollar imaging systems and other capital equipment.Construct health hazard evaluations and preliminary risk assessments via field action investigations, sourcing information from diverse work streams (e.g., design, manufacturing, complaint handling unit).Made presentations to senior management with recommendations for type of field action to be take.Authored 806 Letters to FDA, Customer Information Letters, Product Hold Statement, and other Field Action documents.Interfaced with domestic and international Business Units and oversaw conduct of field actions.Point of contact with FDA during the conduct of the field action.

Working as project manager for Stelex, Inc. provided regulatory compliance consulting services for regulated manufacturing infrastructures. These services include validation services for Process Systems and Equipment, Facilities, Utilities, Automation and Manufacturing Processes in the Pharmaceutical (Finished and Bulk), Medical Device & Diagnostic, Consumer Products, and Veterinary Industries. Validated clean steam controllers for aseptic fill lines with Part 11 compliant PLCs. Programmed PLC Controller steam profile.Developed and validated CIP, SIP, WIP cycles for Pharmaceutical Process equipment, and tanks. Wrote and executed IQ, OQ, PQ protocols for WIP skid. Wrote Operator and Maintenance SOP for Skid.Developed and validated sterilization cycles for autoclaves.Developed Standard Operating Procedures (SOPs) related to processes for Client and reviewed SOPs related to systems validation within Pharmaceutical Sciences operating areas. Generated maintenance, operational, and cleaning Standard Operating Procedures (SOPs) for a wide variety of manufacturing equipment and support facilities.Managed multiple teams at multiple sites in the creation and execution of Computer System Validations (CSV).Performed on site assessments, audits, risk analyses, and client interviews.Managed day to day client interaction and administrate requirements for team I.E. time sheets, onsite housing, expensive reports, month end report to client, etc.Managed day to day client interaction and administrate requirements for team I.E. time sheets, onsite housing, expensive reports, month end report to client, etc.

Working as independent contractor provided regulatory compliance consulting services for regulated manufacturing infrastructures. These services include validation services for Process Systems and Equipment, Facilities, Utilities, Automation and Manufacturing Processes in the Pharmaceutical (Finished and Bulk), Medical Device & Diagnostic, Consumer Products, and Veterinary Industries.Developed comprehensive validation life cycle documents (SDLC), including URS (User Requirements), FRS (Functional Requirements), Validation Plans, Qualification Documents, Trace Matrix, and Summary Reports at various client sites. Reviewed and approved computer system validation deliverables for accuracy, consistency, clarity, and completeness. Responsible for generating maintenance, operational, and cleaning Standard Operating Procedures (SOPs) for wide variety of manufacturing equipment and support facilities.

As Chief of Automation Support (Asst. G6), responsible for all Automation Support activities for Army Reserve Division.Supervised the fielding, maintenance, and operation of 500+ PC LAN/WAN.Responsible for the development of unit web page. Supervised the development and fielding of automated personnel data retrieval system.

As Project Manager oversaw program start-ups, equipment set-up, process validations and technologies transfer from OEM developers to production facilities.Using project management tools concurrently managed multiple OEM projects for single use disposable productsEngineer's technical understanding of manufacturing equipment, validation principles and concepts, regulatory expectations and industry practices, as well as a detailed knowledge of pharmaceutical/medical device processing, manufacturing equipment, and plant utilities.As Project Manager developed product life cycle, including requirements definition, design, development, product/process validation, technology transfer to manufacturing site, and product rollout.Traveled extensively to ensure suppliers conformed to J&J, ISO, NRC, and cGMP standards. Using Six Sigma tools reduced product reject rates by 90% for laser catheters. Managed numerous projects for the production of endoscopic single-use disposable instruments and accessories at outside corporate partners.Conducted experiments, developed labeling, and wrote reports in support of 510K and ISO submissions.Wrote Process Flow Diagrams, and developed streamlined procedures that gave more flexibility to the operational SOPs, while maintaining compliance to FDA, cGMP, and company guidelines.Wrote full suite of validation documentations to include Validation Plans, User Requirements, Functional Requirements, Risk Assessments, Detailed Design Specification, Factory Acceptance Test, Site Acceptance Test, Installation / Operational / Performance Qualification Protocols, Summary Reports, and Trace Matrix at various OEM sites.Reviewed and approved computer system validation deliverables for accuracy, consistency, clarity, and completeness.