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Currently working at Merck in Global Clinical Supply. Systems experience with DCS: Emerson DeltaV, SCADA: Wonderware, PLCs: Rockwell Allen-Bradley, BAS: Siemens Apogee Insight, Siemens Desigo, Historian: OSIsoft PI, Virtual Environments: VMWare and SQL, Control Networks: DeviceNet, AS-i Bus, Fieldbus, Profibus, Modbus, and OPC, Data Analytics: PowerBI, Spotfire, Lab Systems: GE Unicorn, Sartorius BioPAT MFCS, Sartorius AMBR, and Quality Management: SAP, Trackwise. Experienced engineering professional with a demonstrated history of system ownership and leading projects in digital manufacturing, operations excellence & IIoT initiatives within the Pharmaceutical & Biotechnology industry. Skilled in life-cycle management, data historians, DCS systems, integration, change control, validation, and cGxP compliance.I have knowledge of GAMP software development lifecycle, ANSI/ISA-S88, and S95 industry standards. I've worked in cGMP regulated environments specifically FDA cGxP and 21 CFR Part 11 regulations and understand software system validation.
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Associate Director, EngineeringMerck Jan 2023 - PresentGlobal 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. -
Senior Specialist, Manufacturing AutomationMerck Jan 2021 - Dec 2022Technical 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.
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Senior ScientistMerck Jan 2019 - Dec 2020Biologics 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.
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Senior EngineerTakeda Jan 2018 - Jan 2019Tokyo, JpProcess 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.
Will C. Skills
Will C. Education Details
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Villanova UniversityBiochemical Engineering -
Villanova UniversityChemical Engineering
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Loyola High School Of Los AngelesHigh School
Frequently Asked Questions about Will C.
What company does Will C. work for?
Will C. works for Merck
What is Will C.'s role at the current company?
Will C.'s current role is Associate Director, Engineering at Merck.
What is Will C.'s email address?
Will C.'s email address is wi****@****ect.com
What is Will C.'s direct phone number?
Will C.'s direct phone number is +181891*****
What schools did Will C. attend?
Will C. attended Villanova University, Villanova University, Loyola High School Of Los Angeles.
What are some of Will C.'s interests?
Will C. has interest in Poverty Alleviation, Science And Technology, Health.
What skills is Will C. known for?
Will C. has skills like Aspen Plus, Chemical Engineering, Biotechnology, Cell Culture, Engineering, Data Analysis, Technical Writing, Emerson Deltav, Process Automation, Automation, Microsoft Office, Biopharmaceuticals.
Who are Will C.'s colleagues?
Will C.'s colleagues are Lola Fernandez, Edward Vaughn, Hellen Ramirez Gonzalez, Ricardo Pavel Salas Vidal, Stephanie Farmer, Carlos Vera, Jorge Beltran.
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