Computer System Validation expert with twenty-five years experience in the Medical Device and Pharmaceutical regulated environment. Provide definitive compliance technical expertise for Manufacturing; Quality software, hardware and instrument related projects including acting as Subject Matter Expert on 21CFR Part 11.

Titles Held: Senior Validation Consultant; Senior Validation Engineer; Validation Lead; Senior Project Engineer/Validation Engineer; Principal Engineer; Plant Engineer

• Full Validation Life Cycle experience including developing and maintaining Computer System VMPs, Validation Plans, Validation Scripts, and preparing Validation Reports
• Start-ups to remediation projects for pharmaceutical, biotech and medical device companies; experienced in new product launches, FDA 483 Warning Letter Remediation and Consent Decree compliance
• Expert in IQ/OQ/PQ, FDA Compliance, cGMPs Audits, Complaint Reporting Systems, Bar-Code Systems, Vision Systems, PLCs, SOPs, SCADA systems and server-based systems
• Experienced in conducting compliance audits including vendor audits
• Demonstrated success in interviewing organizations to gather understanding of needs and requirements