Jesse Gillikin
President & CEO
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Laura Gillikin
Laura serves as the Vice President of cGMP Validation LLC. Laura has been in the pharmaceutical industry since 1986 and provides our clients with experience in Aseptic Processing and the functions required for support from basic equipment and computer qualification to development of programs required for production and FDA approvals.
Her experiences include projects for qualifying various pharmaceutical and biological process systems and their controls, performing Environmental Monitoring from protocol generation through the baseline data collection at various Aseptic Processing facilities, compiling Steam-In-Place (SIP) protocols and reports for dozens of sanitized and sterilized systems as well as providing technical assistance for sterilization, sample collection and SIP trouble shooting.
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Directors
Saji Jacob
Executive Director - East Region
Saji's expertise evolves from over 16 years of experience as an Automation Engineer, Project Manager and Validation Consultant for various pharmaceutical, biotech, chemical and medical device manufacturing clients with global operations.
As a Director for cGMP Validation since 2003 he manages and continues to develop the East Region operations. He utilizes his expertise to support regional clients with validation automation, project management and consulting services for various types of equipment, processes, systems, and utilities. Project experience includes support for clients in China, Sweden, Spain, England, Germany, Belgium, Venezuela, India, France and Switzerland and all through North America.
His successful project teams, have implemented commissioning and validation projects for a number of Greenfield projects, as well as for various types of facility expansions.
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Ernie Tyler
Validation and Compliance
Varied expertise as a Director of Validation and Compliance with over 40 years experience in the Pharmaceutical, Radiopharmaceutical, Medical Device, Bulk Chemical and Contract Manufacturing Industries.
As well as having a background in consulting, materials management, quality assurance, information management systems, distribution, export, customer service, facility design/construction, engineering and project management.
he is responsible for coordinating and executing validation activities and providing regulatory guidance to our clients.
Versed in Radiopharmaceuticals, he has setup and qualified numerous QC laboratories worldwide which included installing and qualifing test instruments, GMP training and radioactive safety training.
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Phil Murray
Computer Validation
As a Director of Computer Validation with over 25 years of experience working with computerized systems, including over 21 years of computer validaiton experience for companies in FDA regulated industries, his responsibilities focus on coordination and execution of validation activities.
His expertise includes the execution of computerized system validation projects and compliance auditing and training as well as the implementation of Part 11 Assessment and Remediation Planning.
He has a varied background in working with major pharmaceutical manufacturers in validation and regulatory compliance. Consulting experience includes; validation paroject management and master plans; IQ/OQ protocol development, review, approval and execution; change management; SDLC and software supplier audits; policy and procedure development; quality assurance, comprehensive validaiton for a wide variety of process control (PLC/SCADA), laboratory automation, GMP information systems and FDA inspections.
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Madhukar Mehta
Validation and Compliance
Madhukar has over 20 years of technical and management experience in the pharmaceutical industry related to manufacturing and packaging of dosage forms, process and computer validation, electron document management systems and management of quality systems. His background in computer system validation includes Distributed Control Systems, Laboratory Equipment Management Systems, Alarm and Operator Action Management Systems, Building Management Systems and Batch Report Systems. He has performed equipment and process validation including SIP, CIP, Air Handling Units, and product PQ as well as cGMP Audits, Batch Records review, 21 CFR Part 11 Compliance Assessments and development of Remedial Action Plans.
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Jesse Gillikin
Jesse serves as the President and CEO of cGMP Validation LLC. 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 dozens of 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 more than seventy-five companies, including finished pharmaceuticals, bulk pharmaceuticals, medical devices and biotechnology he has an excellent understanding of industry standards; therefore, enabling him the tools to provide practical and cost effective approaches to validation and compliance.
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Laura Gillikin
Vice President
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Christopher Gillikin
Validation and Compliance
Chris has worked in the biopharmaceutical industry since 1997. He has successfully managed equipment, utility, process and computer system validation efforts for large pharmaceutical and distribution facilities. He brings a strong knowledge of cGMPs and FDA regulations to any project he manages. His background includes sterilization systems, SIP systems, aseptic processing areas, utility generation and distribution, controls and validation of temperature-controlled equipment and environments and experience with a wide range of other pharmaceutical equipment and processes.
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Associate Directors
David Whinery
Dave is an Associate Director responsible for meeting validation project goals and managing project personnel to meet timelines and budgets.
His background in FDA regulated industries, Aeronautics and Mechanical Engineering bring a diverse expertise to share with clients projects. He is able to provide start-up assistance, troubleshooting, engineering studies and installation and operation qualifications for various equipment and facilities. He has generated IQ, OQ and PQ protocols and operation and preventive maintenance procedures including distributed control systems (DCS), SCADA, Automation Systems, Filling Lines for Aseptic Facilities, HVAC, WFI, Deionized Water, Autoclaves, Bioreactors, SIP and CIP Systems, Compressed Air and Medical Gasses, Stability Chambers, Tablet Presses, Filling Lines, Packaging Line Equipment and other process equipment.
Tim Jost
Tim has over 15 years experience in solid dosage, parenteral, LCO manufacturing and packaging facilities. He has a background in consulting, contract research environments, validation, metrology, quality control, production and project management as well as establishing SOPs and Validation Master Plans for various operating companies. Tim is responsible for developing and managing projects as well as execution of validation activities and providing regulatory guidance.
Doug Shaw
Doug has over 14 years experience in the pharmaceutical and biotech industries.
Doug is educated in the validation of Laboratory Information Management Systems (LIMS) for implementation in biotech pharmaceutical manufacturing as well as other automation and computer systems. His previous experience includes assessment and remediation of computer systems under consent decree, implementation of new computer validation programs, software vendor audits and management of large multi-site computer system projects.
Mark Curnutt
Mark has over 25 years experience in the pharmaceutical industry. His background includes coordinating and implementing a Quality Assurance Plan/ Program and Change Control program, managing the generation of protocols, execution of approved protocols as well as writing final reports for various types of equipment, utilities and processes.
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