Subject Matter Experts

Robert is  a process and manufacturing automation and applications professional with over 20 years of experience in the pharmaceutical industry.  He excels in challenging situations across diverse manufacturing environments and is known for building strong, multidisciplinary project teams. Robert’s teams have successfully implemented complex manufacturing solutions worldwide, developing cost-effective solutions that align with larger strategic models.  He has contributed as the past Chair of the ISPE Annual Meeting Planning Committee, a steering committee member of the PAT/LCS Community of Practice, and a member of the Digital Transformation Special Interest Group at the Institute of Measurement & Control (UK).

Dalton has supported GMP compliance projects in the pharmaceutical and medical device industries since 2003. He specializes in verification, commissioning, and qualification activities, particularly in Critical Airflow Visualization. His expertise extends to HVAC systems qualification, environmental certification, and temperature mapping. Dalton also develops specifications and executes protocols for automated manufacturing equipment, chemical processing, fermentation equipment, utilities, packaging equipment, and aseptic processing facilities.

Neil has supported cGMP compliance projects for pharmaceutical and medical device manufacturers since 2001. He specializes in developing and executing specifications and protocols for the qualification and commissioning of facilities, systems, equipment, and components, with a focus on utility, HVAC, and refrigeration systems. Neil also has experience in process validations for pharmaceutical manufacturers and directing temperature mapping for manufacturing and storage facilities. Additionally, he has experience in building commissioning for healthcare and educational facilities.

Bill has supported cGMP compliance projects for the pharmaceutical industry since 2015. Has experience in the development of validation documentation and specifications for equipment including the associated control systems. Has also supported building commissioning for both new construction and building renovations. Experience includes facilities, clean utilities, dirty utilities, HVACR, and inspection equipment.

Peter has supported cGMP compliance in the pharmaceutical industry since 2013 and cGLP compliance in pre-clinical research since 2007. He specializes in verification, commissioning, and qualification activities, particularly for pharmaceutical manufacturing and API equipment. His expertise includes sterile filling, freeze drying, qualified utilities, smoke visualization, and temperature mapping. In pre-clinical research, he has managed and audited infusion and toxicology studies.

Rebecca has supported cGMP compliance projects for the pharmaceutical industry since 2018, focusing on validation and verification of facility and utility upgrades within Drug Products. Her experience includes temperature mapping of controlled spaces, automation testing, and testing and air balancing. Rebecca excels in protocol development, specification development, and change control management, working with systems such as HVAC, cleanroom facilities, and environmental monitoring systems.

Scott is a senior leader with 20+ years of progressive operations leadership, including 20 years in the biomedical/pharmaceutical industry. Leverages strong drive for customer satisfaction, building of high performing teams, analytical decision-making perspective, excellent communication, and diverse problem-solving skills to accomplish business goals and propel technical innovation.

Alex has supported cGMP compliance projects for the medical device industry since 2014. His area of focus in medical device manufacturing is overall quality compliance. His experience includes operations engineering, nonconformance management, design and product risk analysis, process improvements, process validation, and equipment qualification. He also has experience with ensuring compliance of a developed UDI Label to the FDA Regulation 21 CFR Part 830.

Byron’s expertise in building construction began as a construction laborer through high school and college.  He then progressed to HVAC/Plumbing engineering and design and eventually into the Building Commissioning industry.   His extensive knowledge and ability to coordinate with the project team has resulted in improved and efficient operation systems, including expedient resolutions to conflicts.

Jason has supported cGMP compliance projects for pharmaceutical manufacturers since 2015, performing development and execution of specifications and protocols for qualification and commissioning of facilities, systems, equipment, and components with emphasis on utility and HVAC systems. Outside of the pharma industry, Jason has experience with new product launch and quality management in the automotive field.

James has supported cGMP compliance projects for the pharmaceutical industry since 2015. He has experience in the development and execution of commissioning, qualification, and validation documentation for manufacturing, packaging, utility, and facility equipment including their associated control systems.

Arianna has supported cGMP compliance projects for the pharmaceutical and medical device industry since 2018. Her area of focus is qualification of new product development for med device. Her experience includes documentation creation, review, approval, and routing, electronic document database management, and qualification of new medical device product.

As a Regional Director at Performance Validation, Matt leads building commissioning across the Pacific Northwest, focusing on strong relationships, team growth, and continuous improvement. He views his role as an extension of his clients’ teams, understanding their unique needs in sectors like K-12, healthcare, and commercial facilities. With a background in quality assurance, R&D, and automation engineering, Matt is committed to challenging the status quo.

Marc is an experienced Senior Validation Specialist in the pharmaceuticals industry.  He excels in Good Laboratory Practice (GLP), medical devices, biotechnology, and pharma. His expertise includes risk assessment, utilities, and instrument validation, ensuring the highest standards of quality and compliance. Marc holds a Bachelor of Business Administration with a focus in Management from Western Michigan University. With a strong background in quality assurance, he is committed to enhancing product safety and efficacy in the life sciences sector.

As a seasoned Validation Engineer, Ben ensures the quality, safety, and regulatory compliance of pharmaceutical manufacturing processes. With expertise in project management, qualification, validation, and GMP deliverables, he optimizes operations and safeguards product integrity in this highly regulated industry. Early in his career, he specialized in validating automated manufacturing solutions for sterile injectable products, seamlessly integrating cutting-edge technology at leading pharmaceutical manufacturers. Currently, he focuses on qualified utilities and facilities, driven by a commitment to upholding the highest standards of product quality, regulatory compliance, and patient safety.

Denise has supported cGMP compliance projects for the pharmaceutical industry since 2019. Her area of focus is validation and verification of upgrades to facilities and utilities within Drug Products and commissioning of new equipment and automation system. Her experience includes temperature mapping of controlled spaces, automation testing, testing and air balancing, as well as commissioning and qualification of autoclave.

Ted has supported cGMP compliance projects for the pharmaceutical and medical industry since April 2019. His area of focus is validation and verification of the Qualified Utilities within Drug Products and Medical Device Manufacturing. His experience includes Qualified Utilities, commissioning of Drug- Production equipment, Drug-Product equipment testing systems, Medical Device production equipment, PPAP activities, and Computer Systems Validation for both equipment and product.

Derek has supported cGMP compliance projects for the pharmaceutical industry since 2008. He has experience in the development of validation documentation and system review documentation for process equipment including the associated control systems. He has provided support to reliability engineering functions within a delivery device manufacturing facility. Derek has also supported building commissioning for both new construction and building renovations. His experience includes automated storage and retrieval systems and temperature mapping product storage areas.

Andrew has supported cGMP compliance projects for the pharmaceutical industry since 2011. He has experience in development and execution of change controls, commissioning, qualification, and validation for utilities, facilities, computer systems, and process equipment for dry product and drug delivery device manufacturing and packaging.

Shannon is a Senior Validation Specialist supporting the BioTech industry since 2009, specializing in Quality Software Testing and Computer System Validation (CSV). She excels in project management, business analysis, and validation master planning. Shannon’s expertise includes Laboratory Information Management Systems (LIMS), custom software, API integration, and cloud storage. She has led validation projects for genetics reporting databases, ensuring accuracy and compliance through rigorous testing and documentation.

Jalen has extensive experience in facility and utilities validation for life science companies, ensuring compliance and efficiency in his projects. His military background as a Nuclear Machinist Mate, combined with his education from the Nuclear Power School at NNPTC, has equipped him with strong management, leadership, and training skills. Jalen’s diverse experience brings a unique and disciplined approach to both the life sciences and military industries.

Michael has extensive pharmaceutical validation experience, specializing in GMP compliance, process validation, and computer system validation. He is skilled in media fill qualification, cleaning validation, and project management, ensuring robust quality assessments on GMP impact systems. His expertise includes risk and nonconformance assessments, as well as authoring and approving critical procedures. Michael brings a strong background in project engineering, dedicated to upholding the highest standards of quality and safety in the pharmaceutical industry.

Phil is a seasoned Building Controls System Professional, having served as the lead controls engineer for the Microsoft campus from 2015 to 2019, managing over 100 projects and four complete building remodels. From 2019 to 2021, he led the Boeing Long Acres Plant remodel and oversaw all Siemens jobs. Phil has also worked on significant projects for the Port of Seattle SEATAC, Salt Lake City Public Safety Building, and HVAC energy savings projects at Fort Shafter and Schofield Barracks. Additionally, he has provided controls engineering services for various institutions including Western Washington University, public school districts, and multiple military installations.