Our reputation is built upon
the character of our people.
Jean Colflesh,
Office Manager
Jean has an Associate Degree in Accounting from Widener College and has been working in the related field for approximately 20 years. She has worked in the Validation/Engineering industry for approximately the last 10 years. She is responsible for the coordinating, directing and reporting of 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.
Fred DiPasquale,
Director, Control Systems Engineering & Validation
Fred earned his Bachelors Degree (B.S.) in Chemical Engineering from Drexel University and a M.B.A from St. Joseph’s University in Philadelphia. He has been working in the pharmaceutical field for over 20 years. Fred has worked in all facets of engineering, mostly at primary manufacturing/active pharmaceutical ingredient facilities, including process engineering, project engineering, maintenance and facilities engineering, and process control/instrumentation engineering.
Fred started working in automation and automation validation over 13 years ago at bulk vaccine manufacturing and monoclonal antibody (mammalian cell culture) sites. Fred started in traditional DCS configuration, and has been trained in PLC and scalable control system (Delta V) configuration. He has specialized in authorship of functional specifications as well as detailed design specifications, authorship of validation test plans for sequencing and continuous control, coordination of equipment and automation validation on critical equipment, and other design documentation.
Fred has performed 21 CFR Part 11 audits, worked on validation of laboratory and IT systems in addition to his traditional manufacturing and control systems, and completed remediation plans for users/clients. He is a member of AIChE, ISPE, and ISA. He has been guest speaker for monthly meetings for the local chapters of ISA and ISPE. Fred has also previously attained Certified Plant Engineer accreditation from the Association of Facilities Engineers.
Through his experience, Fred has supervised large configuration projects that involved multiple contractors, has coordinated compliance audits between corporate and site staffs, and has managed multiple control and validation projects simultaneously. Fred has also been a licensed Professional Engineer in the Commonwealth of Pennsylvania since 1989.
Christopher Petriw,
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 for 8 years. Chris specializes in process control systems, from large DCS based systems to medium sized SCADA systems involving multiple nodes to PLC systems of all sizes. Throughout his 8 years, Chris has worked on all manor of validation projects aside from just process control systems. 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 Laboratory systems such as LIMS and Chromatography Data Acquisition packages.
Chris began performing validation on process control systems 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, Chris 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 install of all system components.
Richard Tabarrini,
President
Richard earned a B.S. degree in biology from LaSalle University in 1992, and has worked in the pharmaceutical industry for 15 years, 12 of which have 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, sales department and actively managing and executing IT and Laboratory Validation Projects. Richard has developed many 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.
Charles Yardley,
Senior Manager, IT Systems Validation
Chuck Yardley earned his Bachelors Degree from LaSalle University and has also been certified as a Microsoft Windows NT MCSE. Chuck has been working in the validation field for 8 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 8years 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 validation of Ethernet and Fiber Optic based networks, Data Archive based software packages, and Laboratory systems such as Chromatography Data Acquisition packages.
Tim Zaengle, Manager,
Laboratory Systems Validation
Tim earned his Bachelors Degree (B.S.) in Biology from Delaware Valley College and has been working in the pharmaceutical industry for more than 13 years. Tim spent the first 7 years working as an Analytical Chemist in both Research and Development and Quality Control organizations. In this capacity he was responsible for method development and release testing activities associated with both development and marketed products. In addition, Tim also served as the System Administrator for many of the laboratory based computer systems. For the past 6 years Tim has been working in IT Compliance and actively involved in all aspects of Computer System Validation. His experience in this area includes: 21 CFR Part 11 assessment and remediation, authorship of specification documentation (user, functional and design), and authorship and execution of qualification test scripts.
Tim also has over 5 year experience as a Project Manager. In this capacity Tim has overseen several success project implementations relating to both stand-alone and enterprise wide applications, some of which include an enterprise wide Chromatography Data Acquisition System, several Particle Size systems and the selection and implementation of a Laboratory Information Management System. Tim has also participated in numerous vendor audits.
Michael Zanette,
Director, Laboratory System Validation
Mike earned his Bachelors Degree (B.S.) in Biology for the Pennsylvania State University and has been working in the pharmaceutical field for approximately 11 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 9 years ago where he specialized 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.