Work Experience
January 2012 to Present
Senior Engineer, Process Validation Sandoz Inc., Wilson, NC
Responsibilities
• Development and execution of Process Performance Qualifications to meet the requirements of the current guidance.
• Change Management Associated with Process Validation
July 2010 to December 2011
Manager, Validation Hospira Inc, Clayton, NC
Responsibilities
• Management of all process/system validation and equipment and instrument qualification
• Oversight of nine (9) permanent validation staff
Major Accomplishments
• Implemented validation lifecycle approach in accordance with FDA Proposed Guidance for Process Validation
• Implemented risk based approach to change management
• Implemented statistical based sampling rationale
• Defended site validation activities in warning letter related inspections
January 2009 to July 2010
Associate Director, R&D QA Validation Stiefel Laboratories Inc.
Responsibilities
• Review all validation documentation, including Design, Installation, Operational Qualification documents and change controls.
• Oversight of Quality Management system (Deviations, CAPA, Change Control, OOS and Quality Alerts)
Major Accomplishments
• Review of all Validation Life Cycle documents for the Clinical Trials Manufacturing Suite and GMP Warehouse
• Fully trained on Computer Validation Lifecycle and Related Change Control
September 2006 to January 2009
R&D QA Validation Manager Stiefel Laboratories Inc.
Responsibilities
• Review all validation documentation, including Design, Installation, Operational Qualification documents and change controls.
• Oversight of Validation vendor while on site
• Vendor Audits
• Project Management QA Lead for Stiefel and Subsidiary Products
Major Accomplishments
• Development of GAMP 4 styled life cycle for non-computer validation
• Development of Calibration, Preventive Maintenance, Review / Requalification programs
January 2005 to September 2006
QA Validation Manager Alexion Pharmaceuticals Inc.
Responsibilities
• Management of three (3) engineers involved with the qualification, calibration and preventive maintenance of GMP/GLP instruments and equipment
• Assisted in the Validation of the electronic Documentation Management System (eDMS)
Major Accomplishments
• Assisted in the development of Alexion’s Computer Validation / System Life Cycle (CSV/SLC) policy and procedures
• Initiation and Team Participation on Part 11 Remediation effort
• Development of Alexion’s Preventive Maintenance Program
• Assisted in the development of Alexion Quality Policy Manual
September 20, 2004 to January 2005
Contract Validation Engineer DSM in Greenville, NC through InterExec Inc.
Responsibilities
• Qualification of GMP Utilities
June 7, 2004 to August 23, 2004
Contract Validation Engineer Amgen in West Greenwich, RI through VTS Consultants Inc.
Responsibilities
• Execution of Installation and Operational Qualification (IQ/OQ) protocols for protein synthesis mammalian cell culture bioreactors
• Writing Change Management (deviation) documentation related to these IQ/ OQ executions
Major Accomplishments
• Learned the basics of mammalian cell culture and the requirements of related equipment
• Interacted with multiple departments for approval of Change Management documentation
July 2000 to June 2004 AAI International, an aaiPharma Company, Wilmington, North Carolina
Senior Quality and Compliance Specialist II
Responsibilities
• Review of executed batch records.
• Review of Manufacturing Investigations and Deviations
• Review of AAI internal Process Validation, Cleaning Validation, and Utility and Production Equipment (IQ/OQ/PQ) qualification documents
• Auditing of manufacturing operations for CGMP Compliance
• Training for the Review of Validation documents, Personal Protection, Manufacturing New Employee Orientation
Major Accomplishments
• As a member of the Investigation Review Board and I developed related training for, and championed of Root Cause Analysis as applied to Manufacturing Investigations
• SOP coordination for Equipment Control issues at two manufacturing sites
• Provided personnel training for gowning and containment as related to hazardous substances in manufacturing
March 1999 to July 2000 AAI International, Wilmington, North Carolina
Project Manager / Technical Definer
Responsibilities
• Oversight of three (3) Validation Specialists at client sites
• Management of internal and external validation products
• Review of AAI internal Process Validation, Cleaning Validation, Laboratory Instrument and Production Equipment (IQ/OQ/PQ) qualification documents
• Definition of client Validation needs for possible AAI Validation Services contracts, including recommendations for needed system design changes
• Speaking at AAI Pharmaceutical Seminars
Major Accomplishments
• Developed and Executed Qualification protocols for Steam Sterilizer and Depyrogenation Oven used for production equipment of Oncologic Medical Devise
- Detailed data analysis to determine agreement with pre-defined acceptance criteria
- Recommended load design changes to better meet acceptance criteria in less time.
• Represented these Qualifications to the MCA in York, Engla...
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