Kate Ly
Systems Engineer at Noblis Esi
Based in Baltimore City County, United States
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Seniority
Staff
Department
Information Technology
Location
Baltimore City County
Industry
Defense and Space Manufacturing
Company size
272
Contact information
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k•••••••@noblis.org
Phone
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Background
About Kate Ly
Sixteen years professional experience in the Biotechnology, Pharmaceutical, and Medical Device Industries. Thirteen years experience in validation of computerized systems, process equipment and information systems as well as utilities, and facilities qualification in medium and large pharmaceutical companies. Expertise in system design life cycle, specification development, design review and equipment functionality testing. Thorough knowledge of current Good Manufacturing Practices (cGMP), 21 CFR Part 11 and Good Automated Manufacturing Practice (GAMP) regulations. Working knowledge of 21 CFR 820 - Quality System Regulation, ISO 13485. Demonstrated ability to function independently as a Validation Subject Matter Expert within a cross-functional team and address a variety of moderate to complex problems.
Decision-makers
Other people at Noblis Esi
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Sam Durbin
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Matthew Waite
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Juan Hernandez
Policy Analyst · Public Administration & Safety
- CKStaff
Carolyn Kupec
Instructional System Designer · Education
- JAManager
Jack Anderson
Senior Program and Outreach Manager · General Business & Management
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