Speaker Profile

Keith Gibbs
Corporate Manager, Yonkers Industries, Inc.

Keith Gibbs is the Corporate Manager of Technical Services, Commissioning and Qualification for Yonkers Industries, Inc. In addition, he serves as Chairman of the ISPE Project Management Community of Practice and served as a Core Team Member and Author of the ISPE Project Management Good Practice Guide. Mr. Gibbs is also an Instructor for the North Carolina BTEC Validation Academy, teaching Project Execution Planning for Commissioning and Qualification and Introduction to Maintenance Management. Mr. Gibbs is a highly-motivated leader with a proven project management track record. Able to interface with and motivate people at all levels of an organization or project and across all business units, he works diligently on the application of best practices. He possesses an extensive experience organizing and supervising the business activities of project teams, within budget and to tight timetables.

An innovative thought leader who is well respected by industry peers for creative and applicable solutions to complex problems, he has proven planning and brainstorming expertise that has established a framework for successful projects and business practices. Mr. Gibbs is a sought-after trainer and educator who has a gift for motivating fellow professionals to reach their peak performance. Through many years of in the field experience, he possesses a full and applied understanding of the business of consultancy support to industry.

As the owner of Ninja Project Management, Mr. Gibbs relies on his eighteen (18) years of experience in Project Management, Engineering, Construction Management, Commissioning & Qualification (Verification), Validation, Quality Assurance, and Pre-Operations Management Support for the pharmaceutical, biotechnology, semiconductor and utility generation and transmission industries, to help clients succeed.

Typically, responsible for the management of cGMP or specialty projects that involve start-up, commissioning, qualification and validation, he is best utilized for short-term, fast track, complex projects. His greatest strength is applying his expertise to projects that need to be brought back on track, and he is a recognized leader for project salvage and restoration planning. To support these tasks, he is involved in the preliminary design review, constructability review and master planning activities to ensure the integration of all phases of a project in the support of turnover, start-up, Quality Assurance and Validation requirements.

In his career, he has managed the design, installation, start-up and qualification of utility, facility, control and process systems for laboratories and pharmaceutical manufacturing facilities. A leader in the integrated approach to commissioning and qualification, he has extensive experience in authoring and executing test plans and protocols.

A unique specialty is the development of leveraged Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) plans as part of integrated Commissioning/Validation efforts. Another hard-earned specialty is the extensive experience in deviation resolution.

Mr. Gibbs has managed teams from 2 to 40 direct reports on projects from $50,000 to $50,000,000. He has supported innovative projects with full life-cycle involvement, as well as task focused short cycle assignments. Primary goal: Identify needs, plan a solution and execute successfully. In his free time, he runs a small business, Raleigh Llama Salvage and Restoration, where he seeks out and restores items and artefacts of interest to him. He is an avid disc golfer and enjoys time with his family.

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