Jesse Gillikin
President and CEO

Jesse Gillikin is co-founder of cGMP Validation and serves as the President and CEO. Jesse has over 25 years of experience in the pharmaceutical industry, including such quality assurance activities as managing QC laboratories, field auditing, contract manufacturing, and validation for 16 of his 25 years. Jesse's experience provides clients with an outstanding validation resource emphasizing expertise in non-sterile/sterile product and computer validation. His experience with other companies, and as a 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, Jesse assists clients in building validation and compliance programs. He also specializes in establishing cleaning and computer validation 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 dozens of companies including finished pharmaceuticals, bulk pharmaceuticals, medical devices, and biotechnology, Jesse has an excellent understanding of industry standards; therefore, enabling him the tools to provide practical and cost effective approaches to validation and compliance.

Jesse's public speaking engagements include guest lecturer at the European Pharmaceutical Conference in Stockholm, Sweden where he presented his approach to computer validation and 21 CFR Part 11. Jesse received his MS in Chemistry at East Carolina University in Greenville, NC.

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Phil Murray
Director of Validation/Compliance Services

As Director of Validation and Compliance Services in cGMP Validation's Midwest Region, Phil is responsible for developing and managing operations to support area clients with commissioning, qualification, validation, project management and compliance services.

Phil has over 20 years of industry experience working with computerized systems, including 16 years computer validation in pharmaceutical and other FDA regulated industries. His experience includes full-time positions with major pharmaceutical manufacturers and in validation consulting including: validation project management; protocol development, review, approval, and execution; change management; system SDLC and software supplier audits; system specifications; policy/procedure development; Part 11 compliance; quality assurance, and FDA inspections. Systems experience includes PLC and SCADA based process control; laboratory automation; GMP information systems; PCs; networking, and electronic documentation systems.

Phil has closely followed the development, interpretation, and enforcement of 21 CFR Part 11, and has significant experience with implementation of Part 11 Assessment and Remediation Planning projects.

During his tenure as a Senior Validation Specialist for Bayer Corporation, Phil was instrumental in defining, implementing, and managing a computer validation program that contributed to successful general/pre-approval inspections for a new pharmaceutical manufacturing facility. He successfully defended computer validation documentation during FDA inspections. As a Project Leader, he was responsible for a series of critical solid-dosage process validation projects including the oversight of 100 requisite equipment/utility/system qualification packages for an existing pharmaceutical manufacturing facility.

Phil holds a BS in Management of Computerized Information Systems from Drexel University in Philadelphia, PA.

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Madhukar Mehta
Director of Validation/Compliance Services

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, electronic document management systems, and management of quality systems. Madhukar's 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.

As Director of Corporate Compliance for Catalytica Pharmaceuticals, he was responsible for site-wide cGMP and DEA compliance, PAI Readiness, Quality Systems, and all critical documentation. He acted as host and liaison for all regulatory inspections. As a Manager at Burroughs Wellcome, Madhukar was responsible for all critical documentation including SOPs, master production and control records, analytical specifications, and test methods. He implemented and successfully managed customized batch identification and shop order release through mainframe applications and 21 CFR Part 11 compliant Document Management System. In addition, he successfully supervised Pharmaceutical Manufacturing, Packaging, and Labeling control operations.

Madhukar received a BS in Industrial Pharmacy in India. He earned a MS in Industrial Pharmacy from Massachusetts College of Pharmacy and has earned his MBA from East Carolina University in Greenville, NC.

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Saji Jacob
Executive Director of Validation/Compliance Services

Saji Jacob is Executive Director of Validation and Compliance Services in cGMP Validation's East Regional office. He is responsible for developing and managing operations to support area clients with commissioning, validation, automation validation, project management and compliance services.

Saji has 15 years of experience as an Automation Engineer, Project Manager and Validation Consultant for various pharmaceutical, chemical and medical device manufacturing clients with global operations. He has considerable experience in manufacturing automation and IT systems and maintains excellent relationships with clients and with cGMP Validation professionals performing the work.

Prior to joining cGMP Validation, Saji worked for one of the largest pharmaceutical companies on the East Coast. He supported validation requirements for two capital projects ranging from $200-500M in capital. The projects were inter-divisional IT and manufacturing systems, which were setup and then deployed to multiple sites. Support activities included strategic planning, regulatory guidance development, engineering standards development, review of system life cycle documents, training and project management. Saji employed the risk based approach to validation to meet FDA's current thinking on validation.

As Project Manager for a major distributed control system (DCS) vendor, he was successful in implementing automation and control systems for various clients. The work included project planning, requirements definition, detail design, graphics development, logic development, testing and supporting installation and loop check activities on site.

Saji has a good understanding of domestic and international GMP regulations. His broad understanding of validation and compliance, technical skills, team building and management skills make him a valuable resource for cGMP Validation clients.

Saji received a BS in Instrumentation Technology from Mysore University in India and a MS in Bio Medical Engineering from Drexel University in Philadelphia, PA.

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Christopher Gillikin
Director of Validation/Compliance Services

Christopher Gillikin is Director of Validation and Compliance Services in cGMP Validation's Southeast region. He is responsible for developing and managing operations to support area clients with commissioning, validation, automation validation, project management and compliance services.

Christopher 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 possesses strong knowledge of cGMPs and FDA regulations relating to pharmaceuticals. As a Project Manager, Christopher successfully managed approximately 15% of the workload for cGMP Validation from 2000 to 2005. 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.

Christopher received a BA from East Carolina University in Greenville, North Carolina in 1996.

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Tim Jost
Director of Validation & Compliance

Tim is Director of Validation and Compliance Services in cGMP for the Midwest Region. He is responsible for developing and managing the operations in the Midwest as well as execution of validation activities and providing regulatory guidance.

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.

Tim joined cGMP after working within several pharmaceutical companies where he was responsible for the management of validation programs that included equipment, facilities, utilities, laboratory instruments, computer systems, process and cleaning. He established SOPs and Validation Master Plan for various operating companies.

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Ernie Tyler
Director of Validation & Compliance

Ernie is Director of Validation and Compliance Services in cGMP for the Northeastern Region. He is responsible for developing and managing the operations in the Northeast as well as execution of validation activities and providing regulatory guidance.

Ernie has over 30 years experience in the Pharmaceutical, Medical Device, Bulk Chemical and Contract Manufacturing facilities. He has a background in consulting, materials management, quality assurance, information management system, distribution, export, customer service, facility design/construction, engineering, validation and project management.

Prior to joining cGMP Validation Ernie was Senior Director of Parenteral Operations for Laureate Pharma, L.P. He coordinated the design, construction and startup of an aseptic parenteral facility for the production of sustained controlled release drugs. Coordinated the validation for utilities, systems, processes and equipment. Ernie was involved in supporting and developing the submittal for INDs, CMC section to INDs and NDAs to government agencies. He also was implemental in managing cGMPs, OSHA, DEA and ATF regulations for facility compliance.

Ernie also worked in a consultancy capacity to assist pharmaceutical manufacturers with their design, construction and compliance needs.

Ernie received a MS in Electrical Engineering from Villanova University as well as a BA in Chemistry from West Chester State University.

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