Will C. Email & Phone Number

Global Clinical Supply - Operations & Supply Technology-Leads and supports systems related aspects of new Operations startup.-Lead system-related aspects of new technology deployment such as system development lifecycle (SDLC), assessments of data integrity, privacy, risk, and other aspects necessary for GxP use.-Responsible for the successful implementation of automation solutions, including both platform technologies and associated analytics, reporting, and visualization capabilities to support local clinical supply operations and administrative business processes.-Develop and complete appropriate system validation, change control, and testing documentation.-Own and support the collection and archival of compliance-focused facility and equipment data.-Support of system upgrades/maintenance, and new software/systems install.-Partner with business areas to develop processes to enable use of technology and equipment.-Reviews automation documents, preventive maintenance, and standard operating procedures to ensure compliance with Good Manufacturing Practice and safety.-Develops and supports corrective actions for investigations related to automation or IT systems.-Accountable for implementing system changes and conducting system investigations. -Use technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems.-Supports clinical supply stakeholders and clinical teams involved in deployment of clinical supply technologies.

Technical Operations - Live Virus Vaccines-Direct/prioritize workload activities of a professional staff of 4 – 6 engineers to provide process automation support to enable the reliable and compliant supply of vaccines in our vial and syringe filling area.-Responsible for the resolution of automation problems, implementation of process control, data collection techniques, and troubleshooting in compliance with System Development Life Cycle (SDLC), GMP, safety, and environmental regulations.-Responsible for ensuring automation documents, preventive maintenance, periodic reviews, and SOPs are in an inspection-ready state.-Supports process automation inquiries during internal and external audits/inspections.-Evaluates automated and information technology systems and develops strategies to optimize and ensure the quality and stability of automation systems through future expansion, replacement, or upgrade.-Leads in installing and placing new equipment into operations. Leads development of technical requirements, keeping in mind the associated technology needs, benefits, and risks. -Leads in developing control strategies and apply computerized tools that will deliver tangible improvements to overall production unit performance.-Communicates daily with the operation, technical, and quality representatives within the area of support through the tier process.-Design solutions to ensure the quality and stability of automation systems through future expansions, replacements, or upgrades.-Leverages code structure and system architecture solutions from other factories, projects, and sites to ensure that automation systems are robust, efficient, and consistent with industry standards.-Leads complex software system testing and validation procedures.

Biologics Process Development and Commercialization - Upstream-Supports biologic upstream process development for commercial processes by efficiently developing high yield, robust, and scalable cell culture processes.-Partner with colleagues in downstream process development, analytical sciences, and manufacturing to develop integrated commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.-Provides technical direction for process development, characterization, commercialization, and regulatory filing activities.-Assesses new technologies, sciences, and industry strategies to drive development, innovation, and adoption of new process technologies.

Tokyo, Jp

Process Automation-Assessed, supported, and proactively improved process equipment including CIP systems, chemical distribution systems, and filtration/separation systems. -Troubleshot and diagnosed process equipment across manufacturing suites.-Led CAPAs, perform front-end engineering design of new processes and/or expansion of current processes.-Developed and reviewed equipment specifications, facility layout, and cost estimation.-Reviewed, continuously updated, and standardized current technical documentation and drawings for DeltaV and BAS control systems. User Requirement Specifications, Functional Specifications, Design Specifications, electrical/control drawings, control network diagrams, system configuration, control complements hardware and software settings, panel layouts, Bill of Materials, and Spare Parts lists.-Updated Standard Operation and Preventive Maintenance Procedures for the existing equipment and control systems.-Led process and controls work for multiple small functional projects and/or large capital/functional projects.-Developed and formally executed system/equipment installation, operation and performance commissioning protocols for modified or new equipment and control systems. Assisted in preparation and execution of the qualification protocols.-Partnered with manufacturing and reliability engineering groups to assure continuous improvements in production operations and increase throughput.

Master’S Degree, Biochemical Engineering

Bachelor’S Degree, Chemical Engineering

High School