JEREMY V MALLOY
Greenville,NC
Summary
Dynamic engineering leader with extensive experience at Thermo Fisher Scientific, specializing in validation and compliance. Proven track record in managing multi-million dollar CapEx projects, enhancing operational efficiency, and developing governance frameworks. Expertise in regulatory standards and a strong ability to coach teams, ensuring successful project execution and data integrity.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Capex Engineering / Validation Manager
Thermo Fisher Scientific
Greenville, NC
02.2025 - Current
- Directed CapEx engineering team in prioritizing projects and coaching project leads.
- Ensured compliance with U.S. and E.U. regulatory standards during project planning and execution.
- Created budgets and managed resources for CapEx projects exceeding 10 million USD.
- Developed strategic initiatives to enhance equipment quality and operational efficiency.
- Collaborated with cross-functional teams to optimize workflows for 20+ concurrent high-budget projects.
- Oversaw engineering and validation governance program for new equipment and facility modifications.
- Facilitated conflict resolution and escalations during project execution.
Interim Capex Engineering / Validation Manager
Thermo Fisher Scientic
Greenville, NC
09.2024 - 02.2025
Staff Validation Engineer (CapEx and Computer Systems Validation)
Thermo Fisher Scientific
Greenville, NC
08.2021 - 09.2024
- Led large CapEx engineering teams to ensure compliant planning and issue resolution.
- Maintained engineering deliverables within budget and on schedule for projects exceeding $10 Million USD.
- Applied expertise in regulatory standards, including ISO 9001, 14644, and Eudralex Annex 1 and 11.
- Developed Commissioning Qualification Validation (CQV) protocols as part of the Validation Engineering process.
- Specialized in CSV for SCADA, D/3, Delta V-managed systems, and PLC-controlled equipment.
- Ensured compliance with FDA’s 21 CFR Parts 210, 211, and 820 regulatory standards.
- Provided technical guidance on dry and moist heat sterilization standards such as ISO 20857 and EN285.
- Demonstrated proficiency in ICH Q7 (API), Q8 (Pharma Development), Q9 (Risk), and Q10 (Quality Systems).
Senior Validation Engineer
VWR-Avantor Scientific
Solon, OH
01.2021 - 08.2021
- Established internal validation philosophy and governance procedures for quality deliverables.
- Demonstrated proficiency in developing and testing CQV protocols.
- Analyzed manufacturer/vendor FAT/SAT to optimize processes.
- Conducted validation assessments on new and legacy equipment.
- Coordinated product Process Validations (PVs) and equipment Performance Qualifications (PQs) with cross-functional teams.
- Guided junior staff in execution support, ensuring timely project deliverables.
- Developed cleaning validation worst-case rationales alongside senior scientific staff.
- Managed validation activities for new and expanded GMP production facilities.
Validation Engineer
Xellia Pharmaceuticals
Cleveland, OH
08.2016 - 12.2020
- Developed and tested CQV protocols to ensure compliance with regulatory standards.
- Ensured adherence to FDA’s 21 CFR Part 210, 211, and 820, Eudralex Annex 1 and 11, and GAMP5.
- Created Engineering Studies for validation testing verification.
- Formulated performance and process performance (PQ/PPQ) testing protocols.
- Served as SME for lyophilizers and autoclaves.
- Trained personnel on environmental monitoring and cleaning validation activities, including swabbing and sampling.
- Administered Kaye Validator Technologies for system configuration, data reporting, and troubleshooting.
- Configured and tested SCADA control systems for clean utilities and event reporting.
Education
B.S. - Environmental Science
American University
West Virginia01.2018
A.S. - Biological Sciences
Columbus State Community College
Columbus, OH01.2009
Some College (No Degree) - Data / Computer Science
Lewis University
IllinoisSome College (No Degree) - Biological Sciences
The Ohio State University
Columbus, OHSkills
- Validation group leadership
- Governance development
- Engineering and validation management and planning
- Computer system validation
- Data integrity
- Regulatory compliance
- Cleaning validation
- Equipment validation strategies
- Technical writing
- Process engineering
- Lyophilization and sterilization expertise
- Sterile pharmaceutical manufacturing
- Isolator and RABS technologies
- IT technologies including VMWare and VirtualBox
- Microsoft Office Suite proficiency
Certification
• PDA Validation of Dry Heat and Moist Heat Processes Certification, 09/19
• Computer Systems Validation and Data Integrity Certification, 12/19
• Requirements for Computerized Systems Validation and Compliance, 04/21
• Thermo Fisher Scientific Leadership Training Program 2023
• PDA 593 Fundamentals of Automated Visual Inspection, 06/24
• Computer Systems Validation and Data Integrity Certification, 12/19
• Requirements for Computerized Systems Validation and Compliance, 04/21
• Thermo Fisher Scientific Leadership Training Program 2023
• PDA 593 Fundamentals of Automated Visual Inspection, 06/24
References
References available upon request.
Timeline
Capex Engineering / Validation Manager
Thermo Fisher Scientific
02.2025 - Current
Interim Capex Engineering / Validation Manager
Thermo Fisher Scientic
09.2024 - 02.2025
Staff Validation Engineer (CapEx and Computer Systems Validation)
Thermo Fisher Scientific
08.2021 - 09.2024
Senior Validation Engineer
VWR-Avantor Scientific
01.2021 - 08.2021
Validation Engineer
Xellia Pharmaceuticals
08.2016 - 12.2020
B.S. - Environmental Science
American University
A.S. - Biological Sciences
Columbus State Community College
Some College (No Degree) - Data / Computer Science
Lewis University
Some College (No Degree) - Biological Sciences
The Ohio State University