Paul Hackett Email & Phone Number

Princeton, New Jersey, Us

Implemented o9's Digital Control Tower to achieve real time visibility for our end-to-end supply chain. Integrated internal and external partners including 3PLs and CMO manufacturers. Automation of manual data aggregation reduces human error and saves planning team 90% of their time.Served as Business Lead for DSCSA Readiness program (Drug Supply Chain and Security Act) to meet all federal serialization requirements going into effect by November 2023. System Owner of EPCIS system of record, Optel Verify Brands, integrating all external partners for data transfer. In charge of building roadmap to close current gaps to FDA guidance and implementing procedures to carry out 3911 investigations, verification, and product tracing.

Dublin 2, Ie

Ingested data from 6 source systems to the Enterprise Data Lake (EDL) to consolidate product related information for the Product Data Hub (PDH) and downstream consumers. Performed Source to Target Mapping (STM) and defined transformation logic for various fields (e.g., Oracle EBS to SAP material numbers, batch numbers, and plant codes).Led offshore development team through various development activities including transformation rules, data profiling and SQL query analysis, unit testing, and creation of data dictionaries.Responsible for Match and De-dupe workstream for the Product Data Hub, which aimed to match regulatory records with associated SKU numbers in a many-to-many relationship. Composed Common Data Model (CDM) for PDH entities with relationships, primary keys, and foreign keys

Dublin 2, Ie

Interfaced a Manufacturing Execution System (MES) with OSI PI data historian and shop floor equipment to support Cell Therapy manufacturing and the transition from paper batch records to a fully Electronic Batch Record (EBR).Deployed Syncade's Quality Review Module (QRM) to improve error handling both in real time during workflow execution and after batch completion.Implemented InfoBatch reporting software and authored user/functional requirements for User Acceptance Testing (UAT) and Operational Qualification (OQ) of the system.

Dublin 2, Ie

Gathered and authored user requirements for implementation of Emerson's Syncade MES to support CAR T cell manufacturing and conducted Risk Assessments to determine necessary testing level for each requirement.Authored and executed Performance Qualification (PQ) test scripts to ensure end-user acceptance of system functionality.Designed 10 interfaces between Syncade MES and client ERP system to facilitate data transfer throughout the manufacturing workflow.

Summit, New Jersey, Us

Mapped out the IT governance structure for new and evolving CAR T therapy landscape within Celgene. Additionally researched blockchain technology solutions to support CAR T production process and to address unmet systems requirements including material serialization, data integrity and transparency, and Chain of Identity (COI) for the patients' cells along the cyclical supply chain.

Summit, New Jersey, Us

Led an Internet of Things (IoT) Proof-of-Concept pilot project to address predictive maintenance for critical lyophilization motors. Advanced sensors capable of continuous measurement were needed to create a comprehensive data library, which was then analyzed with machine learning to build a predictive model. The project was highly successful and is now being considered for implementation at one of Celgene's manufacturing sites.

Bethlehem, Pa, Us

ABEC manufactures and sells custom made single-use bioreactor vessels, minimizing costs and time spent performing required Clean-In-Place processes. Helped designed and test the next wave of products, including single use fermenters, to build upon ABEC's CSR platform for use in the growing BioPharma industry.

Bremen, De

Researched polyoxometalates (P.O.M.s) alongside a Chemical Engineering Ph.D student at Jacobs University in Bremen, Germany. P.O.M.s have potential to replace platinum as a cheaper and more efficient catalyst in Fuel Cell redox reactions, thus making Fuel Cells a competitive player in the world energy industry.

Switzerland 🇨🇭 , Ch

Previously an intern in the Operations branch of RMS, it was helpful to gain an insight to the Quality aspects of the site and organization.

Switzerland 🇨🇭 , Ch

As an intern in the Validation Department of Roche Molecular Systems, I saw the measures that the company has to take to adhere to industry standards. I became familiar with the documents, procedures, and parameters of the validation process, which assures that each diagnostic kit meets the necessary criteria and specifications.

Bachelor Of Science (B.S.), Chemical And Biomolecular Engineering

Biochemistry

Education record