The Pivotal Role of the System Owner — From Project to Operations

Life sciences companies of all sizes and stages of evolution frequently struggle through the transition between project and operations. Projects are generally governed by an emphasis on the rigors of good engineering practice (GEP), while operations are typically dominated by the more nebulous discipline of human performance (HP). In this webinar, the featured speakers explore the key role of the system owner in facilitating the transition from project and operations, by bridging the gap between the disciplines of GEP and HP. They review the purpose and processes behind each of these disciplines, manifested in a vertical startup approach for new life sciences facilities.

The speakers will provide a history of the evolution of the system owner role in the context of engineering projects within the life sciences industry, then offer a more robust definition for application at a program level. They then establish the business case for early emphasis on the role of system owner in the project life cycle and conclude that this role should be neither a “collateral” assignment, nor an afterthought. The webinar will provide example scenarios in which the presence or lack of a system owner is shown to significantly impact project outcomes, both during the project phase and during the transition to operations. Involving the system owner earlier in the engineering process can yield additional returns during continuous operations.

Join this webinar to get specific recommendations on how to identify, train and empower system owners to ensure successful outcomes and transitions to operational readiness. Get insights into a baseline job description for the role, the skill sets to be emphasized in hiring versus training and an ideal timeline for hire relative to a given project schedule. The speakers will provide the basic elements of an effective System Owner Program to assure the continuity of value throughout the lifecycle of the facility.

Speakers

Aaron Roth, Associate Director, Global C&Q, CAI

Aaron Roth is a seasoned Consultant and Project Manager with over 15 years professional experience in the fields of engineering operations, engineering program management and quality risk management in the pharmaceutical industry and the nuclear Navy. Aaron is the lead subject-matter expert for good engineering practice and engineering quality processes, and is a subject-matter expert in quality risk management, commissioning, qualification and validation program development and implementation, biotechnology, aseptic manufacturing and owner’s project management. Aaron is responsible for developing and implementing engineering programs, and processes, as well as risk-based commissioning and qualification programs and projects, with a focus on assessing and training clients regarding transition to risk-based approaches.

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Harry Benson, Director, Human Performance, CAI

Serving as the Global Director Human Performance Services at CAI, Harry Benson leads a team of experienced professionals in developing and executing programs, processes and tools with clients to standardize and improve the performance of their people. A former nuclear-trained submarine officer, he is an expert in organizational culture and structure, along with learning solutions design and delivery with over 20 years of experience in applying current methods for organizational effectiveness within highly technical environments. His methods have driven measurable improvements for a wide range of companies.

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