Business Details
5 Years
experience
Custom Process Engineering Solutions for Biopharma
GMP Engineering is a boutique process engineering, project management, and consulting firm dedicated to delivering comprehensive solutions for the bio-pharmaceutical and GMP-compliant industries. Our mission centers on providing 'right first time' full project lifecycle support, from conceptual design to handover, ensuring client success through precision and innovation. With over 100 bio-pharma projects completed globally, our team combines the expertise of seasoned professionals with the energy of emerging talent, fostering a culture of collaboration and continuous development. We specialize in custom design, project execution, and integration of process-critical infrastructure, adhering to cGMP standards and FDA approvals. Our approach emphasizes clear communication, interactive visualization tools like virtual reality, and a stage-gate consultative process to align with client needs. We bring decades of international experience across the Americas, Europe, and Asia, managing capital projects exceeding $400 million while maintaining a focus on quality, compliance, and operational excellence.Our cross-disciplinary teams deliver tailored solutions for facility design, process optimization, validation, and compliance, ensuring seamless project execution within client organizational structures. By leveraging advanced technologies and a client-centric methodology, we enable efficient transfer of information among stakeholders, reducing risks and enhancing outcomes. Our commitment to innovation is evident in our use of 3D modeling, computational fluid dynamics, and modular facility solutions to address complex challenges in biotech and pharmaceutical manufacturing. Through this integrated approach, we consistently deliver high-quality projects on time and within budget, building long-term partnerships with clients in the life sciences sector.
Services
Process Engineering
Project Management
Validation Services
GMP Consulting
Risk Assessments
Facility Design
Process Optimization
Compliance Auditing
Virtual Reality Design
Containment Solutions
Details
- Year established: 2021
Highlights and features
- We have completed 100+ bio-pharma projects globally with capital investments exceeding $400 million.
- Our team integrates senior experts with emerging talent for cross-generational knowledge transfer.
- We employ virtual reality and 3D modeling for precision design reviews and error reduction.
- We deliver full project lifecycle support from conceptual design to commissioning.
- Our international experience spans the Americas, Europe, and Asia across diverse regulatory environments.
Associations and certifications
- FDA
What people say
Breath of fresh air
Unique team
Right first time success
Interactive visualization
Precision installation
Services
Process Engineering
We deliver end-to-end process engineering solutions for biopharmaceutical and GMP-compliant facilities. Our expertise includes material balance calculations, process flow diagrams, and equipment specification. We specialize in aseptic manufacturing, bioreactor design, and containment technology to meet stringent regulatory requirements.
Project Management
Our project management services cover the full lifecycle from concept to handover. We provide cost control, scheduling, procurement support, and modular facility solutions. Our approach ensures seamless integration with client teams while maintaining compliance with cGMP and FDA standards.
Validation Services
We develop and execute validation master plans, cleaning validation protocols, and process validation strategies. Our services include computer system validation, commissioning, and qualification protocols to ensure regulatory compliance for pharmaceutical manufacturing facilities.
Virtual Reality Design
Our virtual reality design solutions enable interactive project reviews through 3D modeling and Hololens technology. This approach enhances communication among stakeholders, reduces design errors, and facilitates client approval of complex facility layouts and process systems.
Containment Solutions
We specialize in designing containment systems for handling potent compounds, including OEB-5 materials. Our solutions integrate biosafety, isolator technology, and hybrid single-use systems to protect personnel and product integrity in pharmaceutical manufacturing environments.
People
Sam Lombardo
President
As President of GMP Engineering, Sam Lombardo leads strategic growth initiatives and client relations. With extensive experience in process engineering, he drives innovation in pharmaceutical facility design and project execution.
Timothy Leung
Technical & Operations Director
Timothy Leung oversees technical operations and project delivery at GMP Engineering. His expertise in engineering execution ensures compliance with cGMP standards while maintaining operational efficiency across international projects.
Michael Mellor
Process Containment SME
Michael Mellor specializes in process containment solutions for high-potency compounds. He develops engineering controls and safety protocols to ensure compliance with OEB-5 requirements in pharmaceutical manufacturing facilities.
Ali Soeherman
Technical Development Manager
Ali Soeherman leads technical innovation at GMP Engineering, focusing on virtual reality design tools and 3D modeling applications. He enhances project visualization and client collaboration through digital engineering solutions.
Scott Kaplan
Director of Sales
Scott Kaplan manages business development and client acquisition for GMP Engineering. He connects life sciences companies with tailored engineering solutions for facility design and process optimization projects.
Questions
What industries does GMP Engineering serve?
We specialize in bio-pharmaceutical, vaccine manufacturing, active pharmaceutical ingredients, and plasma-derived protein manufacturing sectors.
Do you handle international projects?
Yes, our team has completed projects across North America, Europe, and Asia with global regulatory compliance expertise.
What validation services do you offer?
We provide validation master plans, cleaning validation, process validation, computer system validation, and commissioning protocols.
How do you use virtual reality in engineering?
We employ VR for interactive design reviews, facility walkthroughs, and error reduction through 3D modeling visualization.
Can you handle potent compound containment?
Yes, we design OEB-5 compliant containment systems with isolator technology and hybrid single-use solutions.
What project phases do you support?
We provide services from conceptual design through commissioning, including feasibility studies, detailed engineering, and startup support.
