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
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)
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)
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)
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)
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
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
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
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