John D. O’Brien
Lockport,Illinois
Summary
Hard-working talented engineering professional with a combined 9 years of experience in pharmaceutical, biotechnology, and medical device industry qualification and validation. Experienced with leading large-scale projects and optimizing workflows. Utilizes strategic planning and resource management to ensure project milestones are met. Track record of fostering collaborative team environments and achieving high-impact results. Experienced in execution, leading and applying innovative practices, in-depth testing evaluation and analysis skills, and knowledge of FDA regulations (21 CFR) and applicable standards (ISO / USP / EP). As a highly motivated and adaptable individual, I excel in collaborating with cross-functional teams and tackling challenges with creativity and precision. I am committed to continuous growth and stay updated on industry trends and best practices. Ready to utilize my skills contribute meaningfully to your team and make a significant impact.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Account Manager, CQV Manager, Senior CQV Engineer
VEQTOR LLC
Rosemont, IL
01.2020 - Current
- Oversee Account Management: project contacts, proposals, and budgets for clients in Illinois, Texas, and California
- Act as a site lead for company commissioning and qualification activities (See Senior Qualification Engineer)
- Responsible for 6+ direct reports.
- Generation of business estimates and proposals for new and existing projects.
- Responsible for monitoring of routing and approved Purchase Orders (PO).
- Established strong working relationships with clients through exceptional communication skills, fostering trust and collaboration.
Commissioning & Qualification Lead/Project Manager
Leading Global Pharmaceutical Company (via VEQTOR LLC)
North Chicago, IL
12.2021 - Current
- Provide project management support for pharmaceutical expansion projects with a global pharmaceutical leader.
- Manage a cross functional team of eight (8) consultants providing commissioning and qualification documentation generation and execution support for multiple facility, Utility, and Equipment expansions.
- Development and management of change controls and validation plans via appropriate Quality Management System (QMS) (i.e Trackwise, Veeva)
- Overseeing quality documentation lifecycle from planning to approval, including but not limited to: User Requirement Specifications (URS), System Risk Assessments (SRA), Design Qualifications (DQ), Factory and Site Acceptance Testing (FAT/SAT), Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) and final reports utilizing risk-based C&Q principles.
- Design and execution of temperature mapping studies (warehouse, cleanrooms, cold storage units)
- Generation and Approval of global and site governance documentation (SOP, BOP).
- Responsible for review, management, and tracking of deviations, change control documents, notice of events, CAPAs, batch records etc. utilizing Quality Management Systems (QMS).
- Management of large portfolio of project budgets, providing scheduling updates to client, and driving C&Q Schedule.
- Developed and maintained project budgets to control costs and meet organizational and project goals.
Senior Qualification Engineer
Leading Global Diagnostics Company (via VEQTOR LLC)
Des Plaines, IL
01.2020 - 12.2022
- Development of Risk-based C&Q program.
- Responsible for creation and implementation of Validation/Qualification Project Plans.
- Development of Functional Design Specification (FDS), electrical schematics, User Requirements Specifications (URS), Equipment System Specifications, and Product Recipe Specifications
- Responsible for review, management, and tracking of validation protocols and reports including deviations, change control documents, notice of events, CAPAs, batch records etc. utilizing Quality Management Systems (QMS).
- Assist with preparation and review of FMEA risk assessment analysis.
Qualification Engineer Consultant
CSL Behring LLC (via VEQTOR LLC)
Kankakee, IL
01.2017 - 03.2020
- Development and execution of FAT, SAT, Commissioning, Installation Qualification (IQ) and Operational Qualification (OQ) Protocols for Bulk Manufacturing and R&D Equipment.
- Development and execution of FAT, SAT, Commissioning, Installation Qualification (IQ), and Operational Qualification (OQ) Protocols for new Serialization/Vision Systems for multiple products catering to both domestic and international markets (Europe, Asia, South America, etc.) across multiple packaging lines.
- Development and execution of FAT, SAT, Commissioning, Installation Qualification (IQ) and Operational Qualification (OQ) Protocols for Packaging and Inspection systems.
- Development of Functional Design Specification (FDS), electrical schematics, User Requirements Specifications (URS), Equipment System Specifications, and Product Recipe Specifications
Validation Engineer Consultant
CSL Behring LLC (via VEQTOR LLC)
Kankakee, IL
01.2016 - 06.2017
- Development and execution of cleaning validation protocols for bulk manufacturing tanks, filter presses, transfer lines.
- Development and execution of Process Qualification Mixing Study protocols.
- Development and execution of sanitization study protocols for controlled bulk manufacturing areas.
- Protocol Review and generation of final protocol summary reports.
- Recognized deviations from established procedures and collaborated in cross-functional teams to correct manufacturing inconsistencies, resolve discrepancies, and reduce inefficiencies.
- Responsible for review and management of validation protocols and reports including deviations, change control documents, notice of events, CAPAs, batch records etc.
- Generated PQ protocols for validation of utilities, including water, nitrogen, and compressed air.
- Assisted with preparation and review of FMEA risk assessment analysis.
Engineer I
Private Consulting Firm, PTSO Delivery Device Development
Round Lake, IL
04.2015 - 12.2015
- Development of Standard Operating Procedures (SOP) for Test Method Validation (TMV) studies that conform to current regulatory guidelines.
- Designed and conducted testing and Gage R&R studies for verification of TMV.
- Authored test protocols and generated technical reports.
- Provided engineering support for multiple device projects within the group.
Research Assistant I
Rush University Medical Center – Hemophilia and Thrombophilia Treatment Center, Department of Pediatrics
Chicago, IL
11.2013 - 03.2013
- Implemented multiple grant-funded studies of synovitis and hemarthrosis in Hemophilia A (Factor VIII deficient mice), including dissection, sample preparation, molecular, and protein biology techniques in accordance with IACUC guidelines.
- Developed standard operating procedures (SOP) for experimental techniques, analysis of data and literature, and preparation/presentation of manuscripts.
Education
Master of Science - Biomedical Engineering
Ohio University
Athens, OH07.2012
Bachelor of Science - Mechanical Engineering & Minor in Biology & Bioengineering
Iowa State University
Ames, IA05.2010
Skills
- Project Management (Budget, Timeline, and Resourcing)
- Business development
- Cross functional team leadership
- Asset Management Database and QMS Management (Veeva, Trackwise, Maximo)
- Temperature Mapping (Kaye, Ellab)
- Good Practices (cGxP / cGMP / cGLP / cGDocP)
- Risk Based Qualification
- Design & Risk Analysis (FMEA/FMDEA, PRD, FDR, DHF)
- User Requirement and Design Specifications
- FAT/SAT/IQ/OQ/PQ
- Management of Deviations, Corrective Actions (CAPA)
- Quality Assurance
- Data Integrity and Data Security
- Computer System Validation (CSV)
Key competencies
- Test Method Validation
- Cleanrooms
- Serialization Systems
- Packaging and Inspection Systems (Labeler, Cartoners, Casepackers, Palletizers)
- Bulk API Manufacturing (ie Fermenters, Filtration Skids, Filter Presses, Filter Dryers)
- DCS (eg Deltav, SCADA)
- CIP and SIP Systems
- HVAC, Sanitization, and Environmental Monitoring
- Autoclaves/Sterilizers
- Utilities (ie RODI, PW, Clean Steam)
- Process Gases Storage and Distribution (ie CO2, O2, and Argon)
- Bioreactors
- Filling Lines (Isolation)
Technical Experience with:
Certification
- Kneat Paperless Validation Power User Level II
Timeline
Commissioning & Qualification Lead/Project Manager
Leading Global Pharmaceutical Company (via VEQTOR LLC)
12.2021 - Current
Account Manager, CQV Manager, Senior CQV Engineer
VEQTOR LLC
01.2020 - Current
Senior Qualification Engineer
Leading Global Diagnostics Company (via VEQTOR LLC)
01.2020 - 12.2022
Qualification Engineer Consultant
CSL Behring LLC (via VEQTOR LLC)
01.2017 - 03.2020
Validation Engineer Consultant
CSL Behring LLC (via VEQTOR LLC)
01.2016 - 06.2017
Engineer I
Private Consulting Firm, PTSO Delivery Device Development
04.2015 - 12.2015
Research Assistant I
Rush University Medical Center – Hemophilia and Thrombophilia Treatment Center, Department of Pediatrics
11.2013 - 03.2013
Master of Science - Biomedical Engineering
Ohio University
Bachelor of Science - Mechanical Engineering & Minor in Biology & Bioengineering
Iowa State University