Jay Bates Email & Phone Number

Wayne, PA, US

Operations lead for LGBTQ+ EBRG.

Ringaskiddy, IE

• Served as an automation project lead for the integration of an Allen Bradley PLC based system with DeltaV, including design, vendor management, coding in DeltaV and RSLogix, and computer system qualification.
• Developed project scope, estimation of hours, cost, and timelines.
• Ensured computer systems were validated according to corporate and GAMP guidelines as well as all applicable computer system validation regulatory requirements, including the development of documentation and test.
• Executed change control; designed, tested, installed, prepared SDLC documentation, presented progress reports to clients, and ensured all changes were completed on time, on target, and in budget.
• Implementation of disaster recovery plans to restore and remediate manufacturing systems after complete system failure due to malware attack.
• Worked with a third party vendor to migrate an inventory management and label system from obsolete hardware and software to currently supported software and hardware, ensuring the vendor met the needs of the client and.

• Contributed systems engineering, computer system validation, manufacturing, equipment, and pharmaceutical industry expertise as a consultant
• Developed agreed upon solutions; designed, tested, installed, and monitored new systems, prepared SDLC documentation (including items such as: design documents, test protocols/scripts, change requests, system.
• Consult with clients to collect information regarding their business and technical needs, evaluate existing systems and processes, and recommend appropriate technologies/equipment and validation plans to meet their.
• Utilize generalist systems engineer skills to meet client corrective and preventative actions, their requests for error correction, system updates and enhancements, and to lead client teams how best to implement.
• Process automation engineering experience in the area of vaccine manufacturing, including fermentation, purification, CIP/SIP, and sterile equipment supply; working with such systems as PROVOX, DeltaV, Infobatch.

Royersford, Pennsylvania, US

Indianapolis, Indiana, US

Served as a vital member of the manufacturing control / IT systems deployment team for the new manufacturing site designed specifically for filling and packaging pharmaceutical products.Worked with local and central IT, quality, and manufacturing personnel and groups, project managers, and the Global and Local Resources Departments to develop validation.

• Provided support to glassware and sterile supply area.
• Established, validated and launched web-based applications that followed the system life cycle methodology and ensured compliance with FDA regulations including 21 CFR Part 11 as well as company standards.
• Provided technical support for MS Access databases, supervised employees and contractors engaged in supporting manufacturing computer systems while ensuring compliance with FDA regulations, internal guidelines and cGMP.
• Upgraded and modified computer systems as necessary which included analyzing options, determining user requirements, system implementation, and conducting system tests to ensure smooth, seamless operations.
• Designed and implemented automation changes required to introduce new and maintain current manufacturing processes in the vaccine manufacturing area.
• Recognized by the company through several awards received for putting forth extraordinary efforts to ensure all quality standards and deadlines were met including installing a data collection system to replace an.

Established the employee resource group with recognitions by the company, organized and orchestrated networking events and provided guidance on company diversity policies

Provide manufacturing and validation support for the startup of a new vaccine manufacturing facility, including process and CIP/SIP Trouble shoot for mechanical, automation, and system design errors

Mba, Information Systems

Certificate, Project Management

Bs, Biology