James Joseph Vincent Catarello
Vernon Hills,Illinois
Summary
Senior engineer with extensive experience at AbbVie specializing in validation management and quality assurance. Demonstrated success in leading cross-functional teams to improve regulatory compliance and streamline equipment validation processes. Skilled in project and risk management, resulting in enhanced operational efficiency and reduced costs.
Overview
10
10
years of professional experience
Work History
Senior Engineer, Validation
AbbVie
North Chicago, Illinois
10.2024 - Current
- Led capital and interdepartmental validation projects to ensure compliance and operational readiness.
- Managed Facility/Utility/Equipment (FUE), Automated Process Control (APC), and Cleaning validation activities.
- Managed contract validation engineers and summer interns to enhance teamwork and project efficiency.
- Updated and organized the Validation Master Plan (VMP) to ensure compliance with regulatory standards.
- Worked with in-house functional support and outside vendors to coordinate required services.
- Coordinated validation change control documentation and electronic quality management system to streamline processes.
- Identified and implemented opportunities to reduce costs, increase flexibility, and generate capacity via process improvement initiatives.
- Interfaced with area managers from the Operations and Quality functions through the Validation Review Board (VRB).
- Ensured integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
- Ensured thorough investigation and timely resolution of issues related to FUE/APC/ & Cleaning validation activities.
- Managed validation related, quality improvement projects to foster compliance to regulatory, corporate and department requirements.
- Represented department in quality audits, both internal and external, in regard to validation and engineering compliance.
- Built strong working relationships with operations and engineering validation disciplines to enhance collaboration and support.
- Initiated Change Records for Standard Operating Procedures (SOP) in support of equipment and operations processes.
- Ensured employee resource allotment and workload requirements were balanced to meet the forecasted needs of the business.
- Partnered with all levels of key business functions to ensure equipment had the functionality and was equipped to support new and ongoing manufacturing studies.
- Maintained equipment reliability expectations in a high-throughput facility.
- Evaluated and balanced short term production support needs with long term strategic objectives of the department.
Quality Engineer, Validation
AbbVie
North Chicago, Illinois
08.2022 - 10.2024
- Developed and executed validation documents to ensure compliance with validation requirements.
- Implemented and maintained an effective Quality system that fulfilled regulatory requirements.
- Adhered to Good Manufacturing Practices (GMPs), ISO:13485, ISO:14971, & 21 CFR 820.
- Ensured that practices & procedures comply with company policies & applicable regulations for the Quality areas.
- Executed tasks to implement VMP and maintain FUE, OT, IT, Cleaning, and manufacturing processes in a validated state.
- Supervised contract validation resources to ensure timely completion of validation activities.
- Represented department in quality audits, both internal and external, regarding validation & engineering compliance.
- Conducted installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and other validation protocols to ensure compliance.
- Documented control of nonconforming products and implemented CAPAs to address root causes in compliance with ISO:13485 and 21 CFR 820.90.
- Participated with plant & external engineering resources on new installations & systems to ensure that factory, site, & C&Q documentation was in accordance with current GMP & supported validation.
C&Q Engineer
BBS Chicago Automation
Bartlett, Illinois
12.2021 - 08.2022
- Led C&Q department, overseeing BBSC C&Q, FAT, and SAT activities to ensure compliance with standards for Life Science, Pharmaceutical, Mobility, Consumer Goods, Electronic Device, Energy Storage, and Department of Defense customers on custom automated machines.
- Directed C&Q department to manage IQ/OQ/PQ/PV activities and conduct subsequent statistical analysis to validate processes.
- Collaborated with cross-functional team of Applications Engineering, Mechanical Design/Build, Electrical Design/Build, Controls Engineering, and PMs to deliver C&Q, FAT, and SAT outcomes across diverse customer projects.
- Audited internal processes and participated in external audits to comply with 13485 ISO standards.
- Actively participated in the Safety Committee Team.
Validation Engineer
ACTALENT
Schaumburg, Illinois
05.2021 - 12.2021
- Project: Stryker Primafit 2.0 UM2 and UM3 Validation
- Executed commissioning and FAT processes for UM2 and UM3 automated machines, ensuring compliance with Class I Medical Device standards.
- Performed SAT for UM2 and UM3 automated machines.
- Performed PV for the UM2 and UM3 automated machines.
- Executed MSA, Gage R&R, and Process Capability studies for the UM2/UM3 automated machines.
- Oversaw EQ processes for UM2 and UM3 automated machines.
- Supported Department of Advanced Operations to support URS/RTM, pFMEA/mFMEA, SRA needs.
- Led Cognex vision system continuous improvement initiative, optimizing system performance and reliability.
- Improved material thread-up efficiency, contributing to streamlined production processes.
Validation Engineer
VEQTOR Solutions
Bradley, Illinois
04.2020 - 05.2021
- Project: Abbvie S27 and S30 Tank Farm Provox to DeltaV Controls and Equipment Upgrade
- Project: Abbvie R10 Filter Dryer and Waste Tanks Project
- Executed installation and verification activities for instrumentation and controls, ensuring compliance with project specifications.
- Project: CSL Behring SAB Tank Upgrade Project
- Conducted Commissioning & PQ Testing on chromatographic instruments, confirming operational readiness and adherence to quality standards.
- Project: MilliporeSigma Ex-Cyte Distributed Controls System Migration Project
- Performed Commissioning & PQ Testing for all hardware/software affected by DCS upgrade, validating system performance and functionality.
Packaging Development Engineer
Fresenius Kabi
Skokie, Illinois
11.2019 - 03.2020
- Supported engineering for device development, infusion mechanism strategy, and packaging of liraglutide combination product.
- Developed dry lab test methodology for verification and validation testing of the combination product.
- Ensured comprehensive testing met DHF deliverables.
- Developed and procured lab test fixtures for V&V testing.
- Utilized statistical analysis to provide objective evidence of such testing.
Scientist
Abbott
Abbott Park, Illinois
06.2017 - 11.2019
- Project: Alinity IA & CC Product Launch
- Executed assay conjugation PQ/V&V runs to validate sensitivity, specificity, stability, and precision for successful Alinity [510(k) FDA Class II Medical Device] product launch.
- Interpreted and executed Alinity CC & IA test protocols to adhere to GxP, including GDP, GLP, & cGMP practices.
- Facilitated root-cause analysis within cross-functional team to identify and resolve issues in an investigative environment.
- Analyzed data within an ELN & EDMS.
- Evaluated data related to CAPA, NCRs, and ERs to support compliance and quality improvement initiatives.
Precision Analyst I
VIDA Diagnostics
Iowa City, Iowa
11.2015 - 04.2016
- Collaborated with cross-functional team on projects leading to early diagnoses for patients with COPD, emphysema, asthma, and lung cancer.
- Executed core Lab Analyst functions to correct abnormalities identified using APOLLO software.
- Analyzed and prepared CT scans for University of Iowa Hospital, ensuring accuracy for diagnostic purposes.
Education
B.S. - Biomedical Engineering
University of Iowa
Iowa City, IA05-2017
Skills
- Process validation
- Equipment validation
- Quality assurance
- Validation management
- Regulatory compliance
- Risk management
- Project management
Graduation Date
05/17
Focus
Cardiovascular Medical Device Design
Degree
B.S. Biomedical Engineering
Timeline
Senior Engineer, Validation
AbbVie
10.2024 - Current
Quality Engineer, Validation
AbbVie
08.2022 - 10.2024
C&Q Engineer
BBS Chicago Automation
12.2021 - 08.2022
Validation Engineer
ACTALENT
05.2021 - 12.2021
Validation Engineer
VEQTOR Solutions
04.2020 - 05.2021
Packaging Development Engineer
Fresenius Kabi
11.2019 - 03.2020
Scientist
Abbott
06.2017 - 11.2019
Precision Analyst I
VIDA Diagnostics
11.2015 - 04.2016
B.S. - Biomedical Engineering
University of Iowa