SUMMARY

• Former co - founder and principal with Sigel Consulting. Mr. Doyle has provided leadership in strategic and development services in the areas of manufacturing intelligence, manufacturing execution systems, automated weigh and dispense, electronic batch records and electronic work instruction applications, supervisory control and data acquisition and shop floor manufacturing automation systems, multi-site / multi-system data aggregation and reporting solutions.
• Application integration, validation master planning, validation protocol generation and execution, software development and change management processes.

PROFESSIONAL EXPERIENCE

SAP MII Solution Architect

Confidential, Somerset, NJ

Responsibilities:

• Providing pre-sales support for MII contribution to overall SAP solutions.
• Providing client requirements interpretation and implementation guidance to MII development team of customized user interface for process order confirmations.
• Designing and prototype development of key manufacturing operations reporting systems.
• Providing shop floor support for system go-live and on-going maintenance.

Consultant

Confidential, Rochester, NY

Responsibilities:

• Providing design interpretation and implementation guidance to MII development team and associated system testing of customized user interface for process order confirmations.
• Performing informal testing to identify required code modifications in MII and SAP as a Solution Stability Team member.
• Providing formal test creation and execution in QA environment using HP Quality Center.
• Providing hyper care shop floor support after system go-live.
• Providing oversight of code modifications and testing of mission critical SAP customization for medical diagnostic film manufacture Imperfection Tracking system.
• Providing requirements documentation and system testing for automatic coating machine integration to SAP through MII.

Consultant

Confidential

Responsibilities:

• Providing primary system architectural design leadership to meet client requirements, technical standards, and future enhancements
• Directing an on-shore / off-shore development team
• Writing and maintaining functional requirements specifications
• Writing and maintaining software design specifications
• Assisting with database design to support custom application functionality
• Creating and Maintaining HTML and JavaScript based web pages
• Configuring Query Templates
• Creating and Maintaining Business Logic Services transactions
• Developing SQL based report queries
• Writing, maintaining and execution of code object unit test scripts
• Writing, maintaining and execution of validation protocols
• Writing and maintaining system administration SOPs
• Creating and maintaining Crystal Reports for enhanced data presentation purposes
• Creating instructor-led and self-directed end user training using Adobe Captivate
• Providing formal system training for site users and system administrators
• Implementing corrective software patches

Consultant

Confidential, Andover MA

Responsibilities:

• Member of a “swat” team retained to complete initial implementation of an MES system
• Designing, coding, testing and deployment of raw material sampling sub-system
• Implementing corrective software patches
• Deployment of application upgrades for qualification
• Installation of MES software for stand-alone development server/workstations
• Creating and Maintaining Crystal Reports for MES data reporting purposes. Reports include advanced grouping and sub-reporting configuration as required.
• Writing and maintaining functional requirements specifications
• Writing and maintaining software design specifications for code objects and SQL database scripts.
• Writing, maintaining and execution of code object and database unit test scripts
• Writing, maintaining and execution of validation protocols
• Providing go-live support for application system releases, service packs and patches
• Providing production help-desk support for site software and data issues
• Maintaining MES system development and management SOPs
• Providing formal training for team members on MES related SOPs

Confidential, Radnor, PA

Manager

Responsibilities:

• Software Development Consultant for multi-site implementation of Manufacturing Execution System for Manufacturing of Clinical Supplies. Provided lead design and development services for new shipping and sampling modules. Implemented various client requested enhancements to existing modules.
• Technical Lead for MES strategy definition for leading disk drive manufacturer. Documented "As-Is" conditions, identified areas for business process improvement, coordinated input from experts for enabling automation technologies for final recommendations.
• Member of the Validation Team for the global implementation of SAP for an international blood fractionation manufacturer. Responsibilities included developing the global Validation plan and system documentation standards for requirements and design definition, reviewing documentation for adherence to standards and interviewing each functional team in order to develop a matrix of business processes with cGMP impact.
• Member of the development team for the Pre-configured Industry System for the Pharmaceutical Industry at SAP in Walldorf, Germany. Reviewed system design and testing documentation from a FDA validation requirements perspective and evaluated suitability of the system for serving the US pharmaceutical industry.

Confidential, Narberth, PA

Senior Automation Systems Engineer / MES Consultant

Responsibilities:

• Technical Lead for implementation of a multi-year, multi-million dollar, paperless validated MES for a BioTechnology Manufacturing Center. Supervised development of the general and detailed specifications for the MES. Created a database configuration tool for assembly of product recipes. Developed and executed validation testing documents.
• Lead Automation engineer and PLC programmer for Water for Injection delivery system. Developed P&IDs and control panel layouts. Designed and programmed control systems using Modicon PLCs. Provided onsite system startup and control loop tuning services.
• Sole developer and start-up engineer of a PLC based automation system for a unique bovine antibiotics delivery product for animal products division of a large pharmaceutical company. Developed P&IDs and control panel layouts. Designed and programmed control systems using Allen-Bradley PLCs. Provided onsite system startup and control loop tuning services.
• Automation system start-up engineer in tablet manufacturing facility for large pharmaceutical facility in Puerto Rico.
• Shop Floor Automation engineer. Designed and supervised startup of various pneumatic and electronic control and monitoring systems for shop floor manufacturing systems in various pharmaceutical companies.
• HVAC automation engineer. Designed and supervised startup of various building automation and supervisory control and data acquisition systems for various commercial and pharmaceutical companies, utilities and government organizations.

TECHNICAL SKILLS

• SAP xApp Manufacturing Intelligence & Integration (xMII, MII 12.1)
• HP Quality Center
• SAP Solution Manager
• HTML JavaScript
• Oracle SQL
• Crystal Reports
• Adobe Captivate
• POMS Procedures Author and Recipe Manager
• Ladder logic and state-transition diagrams for PLCs
• Microsoft Windows NT, 2000, XP Professional
• Microsoft Office product suite
• Microsoft VBA for macro functionality