Our reputation is built upon
the character of our people.
Richard earned his Bachelor's degree in Biology from LaSalle University in 1992, and has worked in the pharmaceutical industry for 20 years, 17 of which include direct involvement with computer validation and regulatory compliance. Prior to founding Covex, he served six years as a Project Manager, an additional two years as the VP of Business Development and also served as a Senior Manager at Ernst and Young, LLP. His role at Covex includes developing and managing the company budget and sales department and actively managing and executing IT and laboratory validation projects. Richard has developed numerous SDLC methodology programs for many of Covex’s customers and develops and delivers many CSV related training programs. He has also achieved certification by the American Society of Quality as a Quality Auditor and has been approved by the Parenteral Drug Association (PDA) for performing PDA sponsored audits.
Jean earned her Associate's Degree in Accounting from Widener College and has been in related fields for approximately 20 years, working in the Validation/Engineering industry for approximately the last 10 years. She is responsible for the coordinating, directing and reporting all financial transactions for Covex and manages the human resource functions of the company. Jean is also instrumental in the development, implementation and communication of Covex policies/procedures.
Director, IT Services
Chuck Yardley earned his Bachelors Degree from LaSalle University. Chuck has been working in the validation field for 12 years. Prior to that he was a network administrator, responsible for hardware (routers, switches, and servers) and software (all Microsoft Windows Operating systems, SQL databases, and Microsoft Exchange Email) systems. Chuck specializes in Information Technology systems, from Oracle and SQL databases to 21 CFR Part 11 “wrapper” solutions. Throughout his 12 years Chuck has worked on all types of validation projects. He has worked on large 21 CFR Part 11 remediation projects as a technical lead for IT Systems validation, as well as, on the development and qualification of data centers and their networks.
Director, Compliance Services
Mike earned his Bachelors Degree (B.S.) in Biology from Pennsylvania State University and has been working in the pharmaceutical field for approximately 18 years. Mike has worked in many facets of the industry, starting in the lab working with industry leading equipment to perform bench chemistry and microbial identification. He moved from the lab into a manufacturing environment where he worked on the scale-up, manufacturing, and testing of different compounds, vaccines, and intermediates. Mike began working in systems compliance approximately 15 years ago, specializing in laboratory computer system operation, automation, validation, and regulatory compliance.
Through his experience, Mike began working on projects as a lead and then as a Project Manager, handling multiple accounts. He is now responsible for the department, which includes projects in the areas of laboratory systems, laboratory based IT systems, data acquisition systems and information management systems. He is also responsible for providing internal and external industry training on many topics including Validation System Life Cycle, 21 CFR Part 11 applicability and adherence, and laboratory systems control. Mike has achieved certification by the American Society of Quality as a Quality Auditor, and has performed many vendor audits in both the US and Europe.
Director, Automation Services
Arun earned his Masters in Electrical Engineering (MSEE) from Yale University and his Master of Business Administration (MBA) in Management of Technology from Rensselaer Polytechnic Institute. He began his career as a Co.Op. student at Johnson & Johnson, Inc., and later moved to Crayola, Inc., where he developed advanced automation expertise with high-speed reciprocating and rotating discrete manufacturing technologies. Fifteen years ago, Arun entered the FDA regulated Pharmaceutical industry through a spin-off venture of David Sarnoff Research Center. Since then, he has consulted with many major US based Pharmaceutical and Biotech manufacturers and several international European and Asian pharmaceutical companies. He now specializes in manufacturing automation within the life sciences vertical.
In his career, Arun has shouldered responsibility for managing up to $20 million scale-up projects for the commercialization of new products including automated assembly, packaging and sterile filling operations, compressed oral dosage forms, and high-speed web based converting. He possesses thorough knowledge of the regulated industry practices including regional safety, electrical code, security and regulatory requirements in Europe, the East and the Americas. At Covex, he is responsible for developing the automation services offering to the North American Biotech and Pharmaceutical industries.
Manager/Computer Systems Validation
Chris earned his Bachelors Degree (B.S.) in Chemical Engineering from the Pennsylvania State University and has been working in the validation field ever since his graduation in 1998. Chris specializes in process control systems and LIMS systems. From large DCS based systems to medium sized SCADA systems involving multiple nodes, to PLC systems of all sizes. His LIMS implementation experience has been varied as well, creating the validation and compliance solution for a LIMS for a single R&D site, to a LIMS spanning 20+ manufacturing sites responsible for all the release of product. Throughout his career, he has worked on all manor of validation projects aside from process control systems and LIMS. Chris has also worked on network validations of Ethernet and Fiber Optic based networks, Warehouse Management and Distribution Center qualifications, Data Archive based software packages, and Chromatography Data Acquisition packages.
Chris began as a Validation Engineer and worked his way up through ever increasing responsibility and project workload diversification. Through numerous exposures to different manufacturing sites and their proprietary system configurations, he has gained valuable knowledge not only in how systems integrate into each other, but also in how to interact with each division's personal to ensure a smooth and compliant install of all system components.
Manager, Compliance Services
Keith earned his Bachelors Degree (B.S.) in Management, with a specialization in Technology Management, from the New Jersey Institute of Technology and has been working in the pharmaceutical industry for 10 years. Prior to joining Covex in March of 2010, Keith worked for a large global pharmaceutical company and was able to progress through roles of increasing responsibility. He started off as a validation engineer supporting information technology, quality management system, and “Legacy” computer system validation / remediation efforts. From there he went on to become a Regional Manager supporting remediation activities in Belgium and the Netherlands; and eventually acted as the Program Manager directing activities in Europe, Asia, and the Americas.
Keith’s experience includes developing and delivering Computer System Validation related training programs both domestically and internationally. Additionally, he has obtained certification through the American Society for Quality (ASQ) as a Quality Auditor and has executed numerous audits in North America and Europe.