Leadership

Member of the Valuation Committee
Member of the Valuation and Global Risk Committee

Mike invested his career of 30+ years in the pharmaceutical industry. Most of his employment was with a large global pharmaceutical company. Currently, he serves as the president of CAI, an engineering consulting company which primarily serves the pharmaceutical industry.  Mike is a Mechanical Engineer with a Master’s in Business Administration. He has a variety of experiences in engineering, operational leadership, engineering leadership, and large-scale project management in diverse global settings.  Mike has delivered major capital projects in the US, Puerto Rico, China, and Ireland.

He has led very diverse teams in very challenging settings. He has integrated himself successfully into a variety of cultures and locations and has inspired teams to achieve very difficult goals in a wide variety of opportunities.   Mike has experience in a variety of types of pharmaceutical manufacturing operations including dry product manufacturing, aseptic manufacturing, API manufacturing, and delivery device manufacturing. He has led engineering organizations, operational organizations, and large project organizations across these types of manufacturing areas.

Chair of Valuation
Member of the Nominating Governance and Compensation Committee

In addition to serving as the company’s CEO, Robert Chew is an internationally recognized compliance consultant in the areas of risk-based qualification, validation, ASTM E2500 (key author of that standard), and ICH-Q9, Quality Risk Management. Mr. Chew has provided quality risk management consulting to some of the largest pharmaceutical and biotechnology companies in the world. Over the past decade, he has spoken at international conferences in the US, Europe, Asia, and South America. He is an official trainer for ISPE’s Commissioning and Qualification Baseline Guide. Mr. Chew is an industry leader in creating value-added approaches to qualification. He was ISPE’s 2008 Member of the Year. He is a member of the Global Pharmaceutical Manufacturing Leadership Forum. He is the chief architect and prospective patent holder for the company’s BioVoke™ GMP Information Management Suite.

Rich is an operation executive with 35 years of experience leading teams to achieve organizational excellence in supply chain, asset management, reliability, and human performance. A lean operation expert, he is personally credited with the lean transformation of 9 manufacturing sites, mentoring over 34 manufacturing sites in advanced lean operations, and designing and implementing asset management strategies at 15 manufacturing sites.

Rich’s operations leadership journey began with a 22-year career in the US Navy and then continued in several key operations leadership roles in three manufacturing companies prior to coming to CAI.

He is currently working toward a PhD in Operations Management at the University of Texas Arlington where his research has focused on Behavioral Operations and Statistics. He holds an MBA from Southern Methodist University.

Alice Redmond is an experienced Regulatory Compliance, commissioning, qualification, and validation subject matter expert with over 25 years of experience in the pharmaceutical and biotechnology industries. She has significant experience with project planning, regulatory compliance, CQ and coordination. In depth understanding of aseptic processing, biotechnology products, oral solid dosages, liquid fill, Lyophilization, and medical devices. Understands FDA regulations, regulatory guidance documents, and ICH guidelines and applies product/process knowledge to develop risk based approaches.

Phillip Pursifull is the Chief Financial Officer for Commissioning Agents.  Mr. Pursifull is responsible for the day-to-day financial operations of the company and supervises all core accounting, treasury, and legal functions.  Mr. Pursifull was also a key member of the transition of Commissioning Agents from a private company to an ESOP held firm, and he has been the ESOP plan administrator since 2008.  Prior to assuming the financial role within Commissioning Agents in 2004, Mr. Pursifull was a field manager with Commissioning Agents performing project work.  Mr. Pursifull has a Bachelor of Chemical Engineering from the Georgia Institute of Technology.

Wesley has 15 years of experience as a global HR executive responsible for HR operations, talent acquisition, talent management, technical training and leadership development, sales training, M&A integration, and process transformation both in the US and for three years overseas. Prior to that, Wesley spent eight years leading consulting and best-practice research on knowledge management, human capital management, and process improvement. Wesley is a sought-out panelist and featured speaker at industry-leading conferences, a patent owner, and author of two books and numerous published articles on best practices on talent management and knowledge management.

Since 2016, he has also served as a Corporate Fellow at the University of Houston Downtown, Marilyn Davies College of Business, where he co-teaches the UH Downtown MBA program’s Interpersonal Leadership Effectiveness in Business and The Business Leader Role in Talent Development courses.

Wesley is a native of Norman, Oklahoma and holds a Bachelor of Arts from Trinity University and Global Professional in Human Resources Certification from the Human Resources Certification Institute. He also completed Six Sigma Green Belt training and the Project Management Certificate program at the University of Houston.

Erik has over 30 years of professional experience in engineering management as well as strategic and operational planning. He has led diverse, cross-functional, and geographically disperse teams on projects of up to $400M involving technical operations, program development, work management, and change management. Prior to joining CAI, Erik was a Director at a Management Consulting Firm serving the energy industry where he managed multiple projects involving major organizational strategy and process transformations including organizational project management maturity, enterprise asset management, predictive modeling, and organization efficiency. Erik also served 22 years as a Naval Officer specializing in the operation, maintenance, and repair of shipboard nuclear power plants and associated systems.

Amanda comes to Commissioning Agents, Inc with 10 years of Human Resources experience. She graduated with a Bachelor’s degree in Public Relations from Indiana State University and a Master’s degree in Management with a focus in Human Resources from Indiana Wesleyan University. Amanda has worked in industries such as non-profit, arts and culture and home healthcare.

Dwayne is an experienced, team-oriented business manager with a highly successful track record with start-ups and turnaround situations. He has more than 11 years’ experience in all phases of operations and plant management with particular strength in maintenance program and procedures development. He is recognized for exceptional organizational building skills as well as the ability to motivate others on all levels in the achievement of individual and organizational goals.

Nick has 15 years’ experience in the Biopharmaceutical, Food, and Personal Care industries and has held consulting and management positions in Process Development, Manufacturing Sciences & Technology, Reliability, and Facilities Management.  Innovation and Digital Enablement have been at the center of his focus in the industry to solve simple problems, and problems simply.  He is responsible for digital transformation consulting in Operational Readiness & Excellence, managing a portfolio of applications that enable business intelligence, and bringing technology to the biopharmaceutical industry that transforms the way we work.   Nick holds a B.S. and M.S. degree in Bioprocessing Science and Bioprocess Engineering, respectively, from the North Carolina State University.

Michael is a highly motivated professional with a strong interest in Pharmaceutical Sciences. He excels in project management, leadership, validation, quality, or production-based roles, helping businesses develop and modify their products or processes for maximum efficiency, functionality, and effectiveness. Versatile and focused, Michael combines superior interpersonal skills with the technical expertise necessary for successful management and adaptability in the workplace. He is committed to continuously improving processes and meeting organizational goals.

Zagros is an experienced CQV Engineer with an extensive Project Management experience. He is highly experienced in laboratory environments with key skills in Molecular Biology, Cellular Biology, Microbiology, Pharmacology & Business development. He possesses valuable experience in both Biotechnology and Medical devices industries with focus on Quality Assurance and Validation. He enjoys working in a challenging, dynamic, independent environment or as a part of a multidisciplinary team.

Harry leads a team of experienced professionals in developing and executing talent programs, processes, and tools with our clients. These services serve to standardize and improve the performance of their people by addressing challenges with organizations, work environments, leadership, and skill development programs. Harry’s prior 24 years’ experience includes roles as Field Engineer, District Manager, Global and National Account Manager, HR Director, and Learning & Development Manager for the IT/Data Center Business. He is a specialist in adult learning & development and data center infrastructure design and operations.

Harry served over 6 years as a Navy Nuclear Submarine Officer, in engineering, operations, and later as a curriculum developer and instructor in Norfolk, Virginia.

Mr. Calhoun has 18 years of Automation Engineering experience to include process automation, process programming and has logged 15 years as an industrial electrician. Kirk’s current responsibilities are to oversee all personnel, recruiting efforts, project management and daily operations within the Mountain States region encompassing 11 states. Kirk has over 7 years of GMP experience including OSD, nutraceutical and biotech with regards to computer system validation, packaging systems optimization, electrical and instrumentation commissioning/documentation and SCADA configuration. Kirk has also managed multiple projects to including resources, schedules, and budgets. Kirk has significant datacenter commissioning experience to include resource management, power quality reporting and electrical systems testing and has filled the role of datacenter commissioning manager for multiple Microsoft datacenters.

Carrie Cash joined CAI 2023 after 15 years in the healthcare industry.  She has seen, firsthand, the importance of “speed to patient” and how the health and wellness of others relies greatly on the knowledge, expertise and accomplishments of CAI agents and the relationships that they have created with companies across the world.

With an education in marketing at Butler University, and a wide-array of experiences in branding, social media and content creation – as well as many years in sales leadership, Carrie leads our marketing team to ensure that CAI’s offerings are well-known, successes are celebrated and our agents in the field feel supported.

Carrie lives in the Indianapolis suburbs with her husband, Jason, and their two boys – Jaden and Tyler.  You will often see her on the sidelines cheering on her boys in basketball, baseball and tennis.

Niall is a highly adaptable and resourceful engineer with experience in the construction and process industries. From his experience to date, he has gained a strong knowledge of mechanical & electrical construction projects and has garnered excellent communication and interpersonal skills enhanced through extensive on-site activities including client meetings and negotiations with sub-contractors. Niall ensures project success through resource mobilization, technical knowhow, a high level of administration and project management skills.

Andrea joined CAI in early 2017 and has over 25 years of experience in the pharmaceutical industry as a Consultant, Project Manager, Production Manager, and Quality Control Manager. He has managed GMP Audits, edited and implemented Quality Systems under ISO 9001 regulations, managed work orders, edited Risk Analysis Documents, and participated in Remediation Activities.

Nathan is a Validation Engineer who has over 14 years of experience operating and maintaining mechanical systems for pharmaceutical engineering and naval nuclear propulsion plants. This experience includes nearly 2 years providing cycle development, characterization, operational qualification, and summary reports and activities pertaining to Tech Transfer activities, 2 years serving as the sole night shift engineering manager for a state of the art Fill/Finish facility, 5 years of supervising inspection, maintenance and repair of nuclear powered ships and submarines and 3 years of experience revising, improving and providing training for Nuclear Field ‘A’ School Machinist Mate students. Nathan is a Qualified Propulsion Plant Watch Supervisor, Quality Assurance Inspector, Fleet Maintenance Support Planner and Master Training Specialist.

John has more than 23 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John is a Quality Systems SME. He has in-depth understanding of tech transfer, supply chain qualification, aseptic processing, biotechnology products (MABs and other therapeutic proteins), oral solid dosage, liquid fill, lyophilization, sterilization, bulk chemical API and medical devices. He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications. John has significant experience in GMP/ISO compliance auditing of manufacturing facilities and supply chain. He is familiar with implementation of Lean principles and tools, Kaizen events, root cause analysis, visual workplace, standardized work and process mapping of supply chain.

James is a project manager with over 25 years of experience in the fields of operations management, commissioning and qualification, overhaul, plant/equipment startup, machinery preventive maintenance analysis, technical writing and review/auditing experience in the U.S. Navy’s Nuclear Propulsion Program and the pharmaceutical industry. He specializes in mechanical and automation project implementation and testing.

Josh has over 27 years of management and operations experience in the United States Navy as a Submarine Officer and Nuclear Engineer and nearly a decade of experience in Building Commissioning and Management Consulting. During his tenure in the United States Navy, Josh held several operational and executive management level positions culminating in his oversight of annual budgets up to $2.9 million, the daily activities of up to 1200 employees, management and coordination of a comprehensive skills-based training program (including operations and maintenance, safety, personnel qualification, and personal professional development), and the development and execution of fully integrated predictive, preventive and corrective maintenance programs. Before joining CAI, Josh was a Senior Associate at a Management Consulting Firm, managing multiple projects involving major organizational strategy and process transformations, including capital program management (up to $200MM in capital budgeting), asset management, organizational efficiency and structure, and in the training environment.

Eoin has over 18 years of experience working as a Project Manager and Validation Engineer with significant experience in medical device and pharmaceutical startup projects.

Mone’t Johnson has been with CAI since 2013 and possesses over 12 years of experience in continuous improvement, commissioning, project management, instrumentation, maintenance, automation, and controls. She has extensive knowledge in PLC-based automation, control systems, vision systems (i.e. Cognex and Omniview), and inkjet printers on packaging lines.

Niall is a project management professional with over 15 years’ industry experience in technological, financial and regulated environments. Niall is currently the Client Manager and Senior Project Manager for all European data centre commissioning, actively managing multiple hyper-scale (five-nines) engagements in various countries. Niall applies rigorous project management, problem solving, lean and continuous improvement methodologies while adhering to internationally recognized processes and standards. He is a highly-regarded, professional, and flexible team leader with extensive people management, coaching and mentoring skills. These attributes have helped him increase customer satisfaction, enhance quality, increase project profitability, and reduce time-to-market.

Over the past 13 years, Jennifer Lauria Clark, CPIP has gained a depth of knowledge of the Global Life Sciences and Mission Critical industries. Her career began as a Validation Engineer and has grown from validation support, to Project Manager, Director of Business Development, and into her current, global role of Executive Director of Strategic Development.

She has knowledge and experience of the quality and operational requirements within qualified environments. She has engineering, installation, testing, operations, quality/regulatory requirement and project management experience with a wide variety of systems. She is also experienced with the execution of capital construction projects in pharmaceutical production facilities and existing cGMP manufacturing environments.

She is highly organized with the intuition to strategically plan needs on long-term projects, support her key accounts, and build CAI’s internal marketing and business development teams. Jennifer has strong relationships throughout the pharmaceutical and biotech industry, which she utilizes to support client and project needs.

Connie has over 15 years of experience in developing, leading, and managing teams of technical and non-technical teams of up to 30 staff including Quality Managers, Quality Engineers, Senior/Junior Quality Specialists, Microbiologists, and QC Analysts. Connie is a Qualified Auditor with experience of FDA/EMA regulatory requirements and inspections applicable to Pharmaceuticals, Biopharmaceuticals, and Medical Device Packaging. She is a practicing QP certifying and releasing finished product in accordance with EU cGMP requirements. Connie is a Quality Leader assuring appropriate life cycle management of the Quality and Compliance systems are developed and implemented to support qualification, technical transfers, regulatory approvals, and ongoing commercial operations.

Glenn advises early stage and existing manufacturers plan and execute their capital projects across multiple work streams, pursuing operational readiness. With 10 years in the industry and over 35 years as a Naval Officer, his network extends beyond his primary Southeast Region. As a member of several professional societies and committees, clients are provided an invaluable and trusted strategic partner.

Dave DiPietro is an seasoned leader with over 30 years of professional experience leading diverse teams of engineers, technicians, builders, and operators in high reliability high paced environments. He has a track record of success delivering high value projects on-time and on-budget. He is credited with delivering capital projects ranging from large cGMP manufacturing facilities to nuclear submarines for the US Navy. Dave joined CAI in 2021 as a Senior Project Manager after a 30 year career in the US Navy.

Grant joins CAI Data Centers Senior leadership team as Global Senior Director of Innovation and Technical Services from Kelvion Group, a world’s leading provider for Data Center cooling solutions, where he served as EVP.

His previous experience includes roles at Schneider Electric, where he was VP, Data Center Global Customer Projects, supporting the end-to-end delivery of Internet Giant customers, and held numerous executive positions in Morgan Sindall, Skanska, Balfour Beatty and AECOM.

Grant holds a MSc Mechanical and Electrical Engineering, MSc Construction Management, received an MBA from Edinburgh Business School and is a Fellow of the Royal Institution of Chartered Surveyors.

I am delighted and very excited to be joining the new Data Center Division at CAI with the responsibility of developing our digital transformation, new technologies and supporting and addressing the needs of key strategic customers.

At CAI our Data Center Customers comprise of Internet Giants, Telco, Edge, IT and Co-location providers where we have extended our offering to provide greater business value than the traditional role of the Commissioning Agent.

Luisa is an Operations Executive with more than 20 years of experience in major pharmaceutical companies and CDMOs, FDA and EMA approved. 

Multidisciplinary work experience and focus on business strategy gained by covering leading roles in Manufacturing Operations, Engineering/Investment Master Planning, Program Management, New Products Introduction, Lean and Operational Excellence, Maintenance and Contractors Management. 

She has a successful track record in using holistic approach to effectively manage changes, leading the transition of the organization to the desired future state, including performance turnaround and restructuring. 

Luisa is a Mechanical Engineer with a Master’s in Business Administration. 

She has a Certification Production & Inventory Management at APICS, and she is currently working on the PMP® certification at Project Management Institute.

Joe Robinson is a consultant and project director with over 30 consecutive years of experience in the fields of start-up, maintenance, engineering, test execution and project management. He has significant experience managing and executing global projects and building client relations. Joe is an accredited Commissioning Professional by the University of Wisconsin and a Certified Pharmaceutical Industry Professional (CPIP). He has over 12 years of experience (Biotech, Sterile Filling and Oral Solid Dosage) in the Pharmaceutical industry in roles that support Commissioning, Validation, Owner Project Management and Construction Management.

Shaun Ross is experienced in the fields of Project Management, Facility Management, and Safety Program Management, primarily in the areas of pharmaceutical manufacturing facility commissioning and qualification. Additionally, he has extensive experience in the planning, management, and execution of biopharmaceutical equipment startup and testing.

David currently serves as the Vice President of Marketing and Consulting Services for CAI. In this leadership role, David keeps up with the latest developments in biopharmaceutical manufacturing and coordinates CAI’s industry-leading Principal Consultants to advance innovation and solve the toughest client challenges. David served on a major pharmaceutical client’s merger integration team and is a 25-year member of ISPE. In his 22 years at CAI David has served in a wide variety of technical, managerial, and technical sales roles. He has over 26 years’ experience in pharmaceutical and biotech manufacturing with a focus on automation and startup project management.

David has spoken on a variety of subjects around computer system validation, project management, and most recently on pharmaceutical industry quality responses to the pandemic. He spent six years in the US Navy in Nuclear Engineering, has a B.S. in Technical Management, and an Executive Certificate in the Business of Life Sciences from Indiana University.

Rich Stanfield is a Project Manager with over 30 years of experience in the start-up, operation and maintenance of systems and equipment, including system and plant commissioning and turnover. He has over 20 years of experience managing projects of up to $2M and leading groups of people ranging from one to over 50 persons.

John is a project manager/systems analyst with over 10 years of experience in multiple industries. He has a demonstrated track record of providing unique solutions to business processes, specifically in maintenance, reliability, and calibration in a pharmaceutical environment.  John displays consistent success in combining excellent performance, resource management and business intelligence into successful projects in a GMP environment.

Nathan Temple is a project manager and licensed Professional Engineer with 20 consecutive years of experience in the fields of start-up, maintenance, commissioning, and qualification. He is a certified Project Management Professional. Nathan has extensive engineering, test execution, and project management experience with a wide variety of systems and equipment. Nathan is a computer system validation subject matter expert providing project consulting and support as well.

John is a seasoned engineer with a background in Mechatronics. He has over 14 years of experience in the medical device, pharmaceutical, animal health, and hospital industries. During his time working in a hospital setting, he gained valuable experience in medical device calibration, maintenance, performance testing and repairs. John has served as an Operations and Engineering manager in a Medical Devices service provider, being responsible for project management, IQ/OQ/PQ, validation and qualification activities for various clients (both startups and established industry leaders). He has experience in addressing audit requests for clients from various regulatory agencies and ensuring continued compliance with regulations. He has further knowledge in sterile packaging design and development for both large-scale clients and novel start-ups.

Frank joined CAI in 2016, serving in technical and business development roles, and is currently Director of Operations for China. Frank has 18 years of working experience in multinational companies in the pharmaceutical industry, including project design, CQV, Project Management, and Sales & Business Development.