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John is an engineer with a diverse background supporting capital projects in the pharmaceutical field. He is currently supporting the on-going maintenance of AbbVie's Global Track-and-Trace Program and the roll-out of new supply chain serialization and aggregation solutions throughout AbbVie's packaging supply chain.
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Senior Engineer - Track And TraceAbbvie Nov 2024 - PresentNorth Chicago, Illinois, Us -
Project EngineerAbbvie Mar 2022 - Nov 2024North Chicago, Illinois, UsImplementation and on-going lifecycle management of AbbVie's Track-and-Trace serialization and aggregation solutions. -
Validation EngineerAbbvie Apr 2019 - Mar 2022North Chicago, Illinois, UsOngoing day to day support of AbbVie's API Pilot Plant and capital project support. Primary project support tied to the commissioning and qualification of a new HPAPI clinical scale production suite and the rebuild of a legacy API production center. Equipment in scope of work included:- Lyophilizer- Tray Dryers- Process Isolators- Bioreactors- Process monitoring equipment- Transfer stations- Heat Transfer Skids- Vacuum Skids- Nitrogen Distribution System- Argon Distribution System- Methanol Distribution System- Ethanol Distribution System -
Project EngineerAbbvie Apr 2018 - Mar 2019North Chicago, Illinois, Us• Generated and executed IOV protocols for Elagolix processing equipment in conformance with current ASTM E2500 guidelineso Process bioreactors and holding tanks ranging in size from 1500 L to 12000 L with associated filtration, mixing, and temperature control systemso Dietrich Engineering Consultants (DEC) integrated powder handling system with charging isolator, big-bag charging station, and milling-pack-off station o Purified Water Storage and Distribution System (IOV and PQ)• Assisted in the generation of all Elagolix qualification life-cycle documentation including a template based approach to Installation and Operational Verification • Executed DeltaV FAT and SAT software protocols in support of equipment qualification -
Site Manager - Abbvie North ChicagoCgmp Consulting Inc. Dec 2020 - Nov 2024Lake Forest, Illinois, UsManagement of ~12 cGMP resources at AbbVie's North Chicago campus. -
Project EngineerCgmp Consulting Inc. Apr 2018 - Nov 2024Lake Forest, Illinois, UsProviding clients with the validation support they need to stay compliant with all current Good Manufacturing Practices through the life-cycle of their project. -
Scientific Review CoordinatorNorthwestern Medicine Nov 2016 - Apr 2018Chicago, Illinois, Us• Acted as the regulatory gateway for project start up, coordinating the review and processing of all oncology relevant protocols opened within the Northwestern Medical network • Maintained ongoing review of all active protocols for compliance and health as established by the NCI guidelines for Protocol Review and Monitoring Systems • Audited all Scientific Review Committee materials for compliance with NCI guidelines in advance of the Comprehensive Cancer Center’s quadrennial NCI Core Grant submission -
Project EngineerBiotechnique Llc Jul 2015 - Oct 2016York, Pennsylvania, Us• Supervised the installation and validation of pharmaceutical processing equipment o Refurbished Hull Production Freeze Dryer/Lyophilizer (FAT, SAT, and IOPQ) o PennTech EVW-100 External Vial Washer (FAT, SAT, and Commissioning) • Executed IOPQ protocols on pharmaceutical equipment, including data analysis and generation of summary report forms o Bosch Liquid Vial Filling Line with Internal Wash, Depyrogenation, Fill, and External Wash • Validation of ISO 5 and ISO 7 production spaces • Provided process development support and established production workflows • Performed aseptic production of cytotoxic and high-potency injectable products and live attenuated viruses • Performed QA review of executed protocols and re-executed non-compliant sections • Led the sourcing and procurement of equipment, consumables, and services for BioTechnique and acted as a primary internal contact for vendors and contractors • Developed and maintained a site-wide organizational timeline for start-up activities -
Associate EngineerBiotechnique Llc Jan 2015 - Jul 2015York, Pennsylvania, UsAs an Associate Engineer at BioTechnique:-Managed projects in support of the start up of BioTechnique.-Specified requirements for equipment and sourced vendors.-Performed TOC, endotoxin, bioburden, nitrate, and conductivity testing on water samples. -Generated SOP's and technical documents for RO-DI, WFI, and Pure Steam utility systems as well as pharmaceutical processing equipment.-Designed facilities and equipment modifications. -
Adventure Learning Programs FacilitatorUniversity Of Wisconsin-Madison Oct 2013 - Dec 2014Madison, Wi, UsALPs is a student organization dedicated to developing cohesion and opening lines of communication for communities in and around the Madison area. Focus areas:-Created programming aimed at developing communication skills, building a sense of community, and increasing productivity.-Organized and facilitated workshops for a diverse range of campus organizations. -
Undergraduate Researcher (Wickens Lab)University Of Wisconsin-Madison Jan 2013 - Dec 2014Madison, Wi, UsPursued independent research under the guidance of lab PI Marvin Wickens and graduate student Chris Lapointe. My project's overarching theme was enzymatic addition of nucleotides to strands of RNA. Project highlights included: - Re-engineered S. pombe Cid1 and D. radiodurans CCA to alter substrate specificity.- Examined the effect of growth conditions on S. pombe Puf3, Puf4, and Puf5 production. -
Undergraduate Research Assistant (Wickens Lab)University Of Wisconsin-Madison Mar 2012 - Dec 2014Madison, Wi, Us-Trained all new employees in lab procedure, general upkeep, and use of lab equipment.-Supported lab staff by making experimental reagents and media, maintaining lab cleanliness, and stocking inventories.
John Nielsen Skills
John Nielsen Education Details
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University Of Wisconsin-MadisonBiochemistry
Frequently Asked Questions about John Nielsen
What company does John Nielsen work for?
John Nielsen works for Abbvie
What is John Nielsen's role at the current company?
John Nielsen's current role is Senior Engineer - Track and Trace.
What is John Nielsen's email address?
John Nielsen's email address is jo****@****ing.com
What is John Nielsen's direct phone number?
John Nielsen's direct phone number is +181570*****
What schools did John Nielsen attend?
John Nielsen attended University Of Wisconsin-Madison.
What are some of John Nielsen's interests?
John Nielsen has interest in Children.
What skills is John Nielsen known for?
John Nielsen has skills like Microsoft Office, Interpersonal Communication, Molecular Biology, Scientific Writing, Molecular Cloning, Team Building, Research, Sanger Sequencing, Pcr, Bacterial Cell Culture, Western Blotting, Rt Pcr.
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