Jennifer McManus
Validation Engineer I at Moderna- Claim this Profile
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Bio
Credentials
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30-hour General Industry
US DEPARTMENT OF LABOR OSHAApr, 2020- Nov, 2024
Experience
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Moderna
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United States
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Biotechnology Research
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700 & Above Employee
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Validation Engineer I
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Sep 2021 - Present
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Barry-Wehmiller Design Group
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United States
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Automation Machinery Manufacturing
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700 & Above Employee
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Validation Engineer
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Sep 2019 - Sep 2021
• Authored and executed Site Acceptance Tests (SATs), Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing equipment at various client sites • Authored User Requirements (URs), Design Requirements (DRs), and Validation Protocols to align with ASTM E2500 • As a QA Specialist, reviewed and approved documentation to aid in the release of the COVID-19 vaccine • Performed root cause analysis (RCA) for protocol deviation investigations • Authored and improved Standard Operating Procedures (SOPs) for new and existing equipment • Facilitated the training of operators on the use of new equipment in manufacturing clean rooms • Maintained a tracker for project hours and status to ensure the project remained on task and within the client’s budget • Mentored new employees throughout their first year of employment on company culture and general knowledge of the industry Show less
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Hikma Pharmaceuticals
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Project Engineering Co-op
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Apr 2018 - Aug 2019
• Installed and commissioned a new environmental monitoring system for the Chemistry, Microbiology, and Stability Departments to replace the antiquated monitoring system • Partnered with coworkers on the installation of packaging and inspection equipment to comply with FDA serialization regulations • Facilitated the onboarding of contractors in the maintenance of GMP critical systems in the production plant • Installed and commissioned a new environmental monitoring system for the Chemistry, Microbiology, and Stability Departments to replace the antiquated monitoring system • Partnered with coworkers on the installation of packaging and inspection equipment to comply with FDA serialization regulations • Facilitated the onboarding of contractors in the maintenance of GMP critical systems in the production plant
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Drexel University
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United States
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Higher Education
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700 & Above Employee
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Teaching Assistant
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Jan 2016 - Jun 2019
• Assist professor in providing direct service, education, and reflection opportunities for engineering students; grade and moderate discussion board posts • Assist professor in providing direct service, education, and reflection opportunities for engineering students; grade and moderate discussion board posts
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exida
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United States
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Engineering Services
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1 - 100 Employee
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Process Safety Engineering Intern
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Apr 2017 - Sep 2017
• Ran regression tests which aided in the release of the DeltaV plug-in for the exSILentia process safety software • Generated “What if” templates which provided an easier way to conduct process hazard analysis using the PHAx tool in exSILentia v4 • Researched and targeted potential clients to bring more opportunities for safety consultation business to the company • Ran regression tests which aided in the release of the DeltaV plug-in for the exSILentia process safety software • Generated “What if” templates which provided an easier way to conduct process hazard analysis using the PHAx tool in exSILentia v4 • Researched and targeted potential clients to bring more opportunities for safety consultation business to the company
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Philadelphia Water Department
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Government Administration
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400 - 500 Employee
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Engineering Intern
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Apr 2016 - Sep 2016
• Worked with an array of drinking water quality sensors and instruments associated with the operation and maintenance of a network of over 40 monitoring sites in Philadelphia • Prepared daily alarm reports, performed sensor QA/QC checks, monthly performance checks and quarterly calibrations on drinking water quality monitoring and contamination warning system sites • Installed portable water quality monitoring instrumentation • Worked with an array of drinking water quality sensors and instruments associated with the operation and maintenance of a network of over 40 monitoring sites in Philadelphia • Prepared daily alarm reports, performed sensor QA/QC checks, monthly performance checks and quarterly calibrations on drinking water quality monitoring and contamination warning system sites • Installed portable water quality monitoring instrumentation
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(USTA) United States Tennis Association
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United States
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Spectator Sports
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700 & Above Employee
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Guest Services Team Member US Open
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Aug 2014 - 2015
• Greet guests as they entered the tennis stadium • Communicate protocol and guidelines to guests in a professional manner • Work with other team members and officials to see to an orderly and efficient progression of matches • Greet guests as they entered the tennis stadium • Communicate protocol and guidelines to guests in a professional manner • Work with other team members and officials to see to an orderly and efficient progression of matches
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Education
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Drexel University
Bachelor of Science (BS), Chemical Engineering -
Iceland School of Energy - Reykjavik University
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The Mary Louis Academy
Regents Degree with Advanced Distinction with Honors