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GxP Impact is dedicated to 'Engineering Success in the Life Science Industry'. We guide organizations, whether emerging or established, through complex industry challenges. Leveraging technology, specialized expertise, and regulatory knowledge, we provide end-to-end, adaptable solutions with a focus on clear communication. Our mission is to transform the challenges our clients face into opportunities, enabling them to deliver innovative and compliant products to patients faster, within budget, and of the highest quality, all while ensuring adherence to regulatory standards. We work to safeguard against the risks of project failure and promote regulatory compliance, with a goal to ensure 'right first time' delivery, cGMP readiness, and ultimately, the improvement and preservation of lives.
Paul Obringer, a Chemical Engineering graduate from Worcester Polytechnic Institute (WPI) near Boston, MA, brings over 25 years of experience in project and engineering management. Throughout his career, he has consistently delivered measurable value and innovative solutions in facilities and engineering. With expertise in manufacturing o
Paul Obringer, a Chemical Engineering graduate from Worcester Polytechnic Institute (WPI) near Boston, MA, brings over 25 years of experience in project and engineering management. Throughout his career, he has consistently delivered measurable value and innovative solutions in facilities and engineering. With expertise in manufacturing optimization, equipment design, and process development, Paul has led high-performing engineering and maintenance teams. He has successfully managed capital projects, including campus master planning, site expansions, and greenfield plant start-ups in biologics, CAR-T Cell Therapy, HVAC, process equipment, and clean utilities. Paul's extensive knowledge of lean methodologies and lean six-sigma culture implementation further enhances his capabilities. He actively contributes to ISPE as a member since 2002 and serves as a facilities track leader.
Nessiem Samuel is an experienced biotechnology leader and expert in the fields of Quality Engineering and Validation. He received his Bachelor of Science in Industrial Engineering and Master of Science in Management, both from New Jersey Institute of Technology. His broad industry experience has spanned manufacturing and pharmaceutical, b
Nessiem Samuel is an experienced biotechnology leader and expert in the fields of Quality Engineering and Validation. He received his Bachelor of Science in Industrial Engineering and Master of Science in Management, both from New Jersey Institute of Technology. His broad industry experience has spanned manufacturing and pharmaceutical, biologics, cell, and gene industries for over 25 years. Nessiem is a certified Quality Engineer (CQE) and Six Sigma Green Belt (SSGB) from the American Society of Quality.
Nessiem is a recognized expert in the asset management lifecycle, including CQV, GLP, Change Control, CSV, process and cleaning validation. He has a demonstrated track record leading and developing major cross-functional teams and has delivered successful audit readiness and PLI pre-inspection and remediation strategies.
Derik Belanger utilizes his 15 years of experience in Asset Management & Reliability as well as knowledge in systems like SAP, BMRAM, Qualer, and Maximo to drive his clients' success.
An Electrical Engineering graduate from American Military University, Derik is a specialist in developing CMMS/ERP/EAM and Asset management programs, transfo
Derik Belanger utilizes his 15 years of experience in Asset Management & Reliability as well as knowledge in systems like SAP, BMRAM, Qualer, and Maximo to drive his clients' success.
An Electrical Engineering graduate from American Military University, Derik is a specialist in developing CMMS/ERP/EAM and Asset management programs, transforming complex processes into efficient workstreams.
His proficiency extends to performing risk and impact assessments, FMEA’s, and Asset Management Strategy planning. Having served in the United States Marine Corps, Derik's leadership, discipline, and excellence continue to shape his career. His passion for introducing transformative solutions and driving efficiency makes him an invaluable asset to any organization aiming for streamlined operations and improved reliability performance.
Joel Richard is an accomplished professional with diverse leadership experiences in both military and civilian sectors. With 8 years of service in the Navy Nuclear program, his unique perspective and exceptional leadership skills have been invaluable. Joel's journey began in the United States Navy, where he oversaw critical maintenance
Joel Richard is an accomplished professional with diverse leadership experiences in both military and civilian sectors. With 8 years of service in the Navy Nuclear program, his unique perspective and exceptional leadership skills have been invaluable. Joel's journey began in the United States Navy, where he oversaw critical maintenance teams on the USS Enterprise and the USS Frank Cable, ensuring operational readiness. Holding a B.E. degree in Nuclear Engineering Technologies from Excelsior University and an M.S. degree in Business Administration from Villanova University, he seamlessly combines his technical knowledge with a strategic business mindset. Joel excels in maintenance management, program development, process analysis, and risk assessment. His leadership abilities drive successful outcomes, delivering results within schedule and budget constraints. Joel's commitment to excellence is evident through his active involvement in industry associations and GxP certifications. He envisions asset intelligence as a key driver of efficiency, safety, and innovation in the pharmaceutical industry, making a profound impact with his expertise.