Our Team
Jesse Gillikin - President & CEO
RESPONSIBILITIES
Jesse serves as the President and CEO of cGMP Validation LLC. He is responsible for overall company activities and the well being of the company.
SUMMARY OF QUALIFICATIONS
Jesse has been in the pharmaceutical industry since 1978 and has experience in validation, managing QC laboratories, field auditing, and compliance including interactions with the FDA. His experience has included working with many different companies in establishing validation and compliance practices. His experience provides clients with an outstanding validation resource emphasizing expertise in non sterile/sterile product, process validation, cleaning validation, and computer validation. His experience with other companies, as well as liaison with the FDA, enables him to provide services including auditing, compliance/validation program building (including change control), and the writing/execution of validation protocols.
In addition to coordinating team activities and managing projects, he assists clients in building validation and compliance programs. His experiences in hosting FDA inspections and assisting clients during FDA reviews provide him with a background of FDA expectations. As a consultant in many companies, including finished pharmaceuticals, bulk pharmaceuticals, medical devices, biotechnology, and 503B pharmacies, he has an excellent understanding of industry standards; therefore, enabling him the tools to provide practical and cost effective approaches to validation and compliance.
EDUCATION
BA in Chemistry – East Carolina University
MS in Electroanalytical Chemistry – East Carolina University
CURRENT PROFESSIONAL MEMBERSHIP
International Society for Professional Engineers
Laura Gillikin - Vice President cGMP Validation, LLC
RESPONSIBILITIES
Laura serves cGMP Validation, LLC as Vice President. She is responsible for management, coordination and execution of validation activities as well as providing periodic GMP audits and compliance guidance for clients as well as overall HR, benefits, training, and quality assurance for the company.
SUMMARY OF QUALIFICATIONS
Laura has been in the pharmaceutical industry since 1986. Her experience in industry includes microbiological testing, quality assurance, managing vaccine production and parenteral manufacturing operations, environmental monitoring, facility qualification, investigations, validation and compliance for human and veterinary applications.
Her experience with cGMP Validation LLC has included working personally with many clients, particularly in the area of aseptic processing and the functions required to support it from basic facility, environment, equipment and computer qualification to development of programs required for production and FDA approval from operations to quality systems.
Her experiences include projects for qualifying various API, diagnostic, medical device, pharmaceutical and biological equipment, process systems and their controls including clean-in-place (CIP), steam-in-place (SIP) for sanitized and sterilized systems as well as providing technical assistance for sterilization, sample collection and SIP trouble shooting.
EDUCATION
BS in Molecular Biology (Cum Laude) – East Carolina University
CURRENT PROFESSIONAL MEMBERSHIP
Parenteral Drug Association
Christopher Gillikin - Chief Operating Officer (COO)
RESPONSIBILITIES
Christopher serves cGMP Validation, LLC as Chief Financial Officer. He is responsible for overall finance, billing, and accounts receivables.
SUMMARY OF QUALIFICATIONS
Christopher has been in the pharmaceutical industry since 1997. His experience with cGMP Validation LLC has included working personally with many clients, particularly in the area of client relations, project management, project budgets, protocol and SOP development.
His experiences include projects for qualifying various API, diagnostic, medical device, pharmaceutical and biological equipment, sterile filling, process systems and their controls including clean-in-place (CIP), steam-in-place (SIP) for sanitized and sterilized products.
EDUCATION
BFA – East Carolina University
Directors
Jeremy Theys - Senior Director of Validation and Compliance
RESPONSIBILITIES
Jeremy is the Chief Operations Officer, responsible for the management, planning, coordination, procurement activities of projects, and business development the for cGMP Validation. On a project level he is also responsible for meeting validation project goals and objectives and managing project personnel to meet timelines and budget. Jeremy is responsible for the coordination and execution of validation activities as well as providing periodic GMP audits and regulatory guidance for clients.
SUMMARY OF QUALIFICATIONS
Jeremy is an Engineer with many years of construction and project management experience. He has over 10 years’ experience working in the Commissioning and Validation field. He has successfully completed many projects up to $100M and managed teams of over 80 full time employees. He has a strong technical background. As an experienced Project Manager and Director, he has successfully completed numerous projects for multiple pharmaceutical, biotech, and medical device facilities. Jeremy has managed projects utilizing a variety of qualification approaches including ASTM E 2500 verification, commissioning and qualification (C&Q), and traditional IQ/OQ/PQ validation. In addition to coordinating team activities and managing projects, Jeremy assists clients in building validation and compliance programs. He has an excellent understanding of industry standards; therefore, enabling him the tools to provide practical and cost effective approaches to validation and compliance.
EDUCATION
BS – Mining Engineering, University of Missouri-Rolla
Dave Whinery - Director of Validation & Compliance Services
RESPONSIBILITIES
Dave is a Director and has been with cGMP Validation since its founding. Dave is responsible for management, planning, coordination, and procurement activities for cGMP Validation. On a project level, he is also responsible for meeting validation project goals and objectives and managing project personnel to meet timelines and budget. In addition to his responsibilities for the coordination and execution of commissioning and validation activities, Dave also provides guidance and performs periodic GMP audits for clients.
SUMMARY OF QUALIFICATIONS
Dave has been in the pharmaceutical and biotechnology consulting industry since 1993. As an experienced director and project manager, he has successfully completed numerous projects for multiple pharmaceutical, biotech, medical device, and animal health facilities. Dave has a thorough understanding of FDA and USDA expectations and industry standards. He has managed projects utilizing a variety of qualification approaches including ASTM E 2500 verification, commissioning and qualification (C&Q), and traditional IQ/OQ/PQ validation. This breadth of experience allows him to easily adapt and tailor a project approach to work within a client’s existing validation program. Dave plans activities of designated projects to ensure that objectives are accomplished within the prescribed time frame and funding parameters and is able to skillfully coordinate work schedules and staffing of personnel for each phase of the project. Dave is particularly attentive to detail in identifying problems, diagnosing causes, and determining corrective actions.
Dave’s experience in FDA regulated industries and his background in aeronautics and mechanical engineering make him a valuable resource for our clients. He is able to provide project management and project coordination support, start-up assistance, troubleshooting, engineering studies, cycle development, commissioning, and qualification services for various types of computer/control systems, process equipment, processes, utilities, and facilities.
EDUCATION
MS in Aeronautics – California Institute of Technology
BS in Mechanical Engineering, Summa Cum Laude – Brown University
CURRENT PROFESSIONAL MEMBERSHIPS
Tau Beta Pi Engineering Honor Society
Sigma Xi Scientific Research Honor Society
International Society for Pharmaceutical Engineering (ISPE)
American Institute of Aeronautics and Astronautics (AIAA)
Todd Buchheit – Compliance and Computer System Validation (CSV) Director
RESPONSIBILITIES
Todd is cGMP Validation’s Compliance and Computer Systems Validation Director, responsible for business development, project organization and management of this sector of our business. As projects are preparing to start, Todd builds project plans for our clients which include timelines and milestones with budgetary tollgates for measuring project progression. He is also often in the field functioning as a liaison with our clients to observe project execution, manage project changes and ensure our team is on schedule.
SUMMARY OF QUALIFICATIONS
Todd is a compliance expert experienced in high level staff augmentation, designing and implementing compliant Quality Systems under 21 CFR, parts 111, 210, 211, 212, 820 and 1271. Compliance services span across industries such as medical devices, nutraceuticals, pharmaceuticals, radiopharmaceuticals, biologics and homeopathic medicines manufacturing. Computer system qualifications include large systems such as Master Control, Siemens Metasys and Syspro electronic batch records, to smaller systems such as TempAlert passive environmental monitoring. He has been directly involved with multiple green-field build teams providing compliance oversight of building design and startup operations. He has over 15 years of industry experience working in regulated environments and over 25 years progressive management expertise while serving on active duty.
EDUCATION
BS – Business Administration, Southern New Hampshire University
MAS – Aviation Operations and Safety, Embry Riddle Aeronautical University
MS – Organizational Leadership, Southern New Hampshire University
Phil Murray – Director - Computer Validation cGMP Validation, LLC
RESPONSIBILITIES
Since joining cGMP Validation, LLC in February 2001, Phil has been responsible for leading a team of processionals that specialize in providing full-service validation of GxP relevant computerized information systems, including manufacturing, laboratory, logistics, and electronic record management applications. As a Director, Phil is responsible for all marketing, sales, technical, regulatory compliance, and commercial aspects of the projects the team performs, and is accountable internally for effective personnel and financial management.
SUMMARY OF QUALIFICATIONS
Phil has over 24 years of diverse experience in planning, performing and managing all aspects of computerized system validation for US FDA and internationally regulated companies. Phil’s experience includes over 10 years in full-time positions with two top-ten US pharmaceutical manufacturers, and over 14 years providing contract validation and regulatory compliance consulting services to over 35 different companies.
Phil has closely followed the development, interpretation, and ongoing enforcement of US FDA and EMA requirements for validation and has significant experience implementing systems that are required to comply with 21 CFR Part 11 and Annex 11. Phil’s expertise is knowing what needs to be done, why, and how to cost-effectively achieve validation for any GxP regulated system in any phase of the system lifecyle, including: system selection due-diligence; software supplier audits; validation planning and project management; development of system requirements and specifications; risk assessment; development, review, approval, and execution of test plans and test cases (IQ/OQ/PQ protocols); change management; and quality assurance. Phil has assisted many clients with their initial implementation of validation policies, procedures, and standards.
EDUCATION
BS in Management of Computerized Information Systems – Drexel University