Daniel Woods Email & Phone Number

Greenville, Nc, Us

Waltham, Ma, Us

Waltham, Ma, Us

Waltham, Ma, Us

● Acting as primary building contact and working resource for Pharmaceutical Development Services (PDS) Filling and Freeze Drying. Provided Technical support for all building PLC and SCADA controlled systems.● Provide 24/7 Project and Troubleshooting support for building SCADA systems and PLC Controlled systems including Vial Washers, Depyrogenation Tunnels, Vial Fillers, Cappers and Trayloaders, and Freeze Dryers.● Serving as system administrator responsible for system user access approval, recipe approval, and process improvement.● Responsible for developing and troubleshooting process controls utilizing Modicon and Allen-Bradley PLCs. Experienced using ProWorx NXT, Unity Pro, Ecostruxure, andLogix 5000● Responsible for developing and troubleshooting Supervisory Control and Monitoring systems utilizing Rockwell Automation RSView32, RSView SE, Factory Talk SE, Aveva Wonderware, GE IFix, and D/3 DCS. Systems control data recording, transfer, and trending; batch reporting and alarming; and recipe management.● Utilizing Technical writing skills to draft, update, review, and approve URS, FDS, SDS documents for multidisciplinary systems and equipment for Change Control Requests and Capital Projects.

Waltham, Ma, Us

● Acted as primary building contact and working resource for Automation and Computer System Validation.● Responsible for generation, review, and approval of VPP, IQ, OQ, PQ protocol and summary packages across multidisciplinary systems and processes.● Provided guidance and oversight as an SME on project and process engineering URS, FDS, and SDS documents.● Responsible for coordinating Site Validation activities with Automation Engineers, IT, manufacturing and filling personnel to test changes to automated production, facilities and utilities systems under commissioning and qualification protocols.● Successfully coordinated and executed validation for multiple large scale shutdown projects simultaneously with the management of multiple validation resources. Successfully completed and summarized activities within tight deadlines allowing shipment of all customer products on time.● Responsible for integrating GAMP 5 principles into site validation and engineering procedural documentation to keep site in-line with current industry best practices.● Represented Computer System Validation in customer meetings and regulatory audits without significant observations.

Morrisville, North Carolina, Us

Morrisville, North Carolina, Us

● Responsible for coordinating Validation activities with Automation Engineers to test changes to SCADA, D/3DCS, and PLC controlled systems.● Responsible for employing principles of GAMP 5 to ensure compliance with regulatory (FDA, EMA, PMDAetc.) requirements and customer requirements for automation systems documentation.● Utilized technical writing skills to design, execute, and summarize Validation Project Plans, InstallationQualifications, and Operational Qualifications for Site Change Control Requests for Automation System Changes.● Utilized Project Management skills to schedule Validation activities to work around manufacturing schedules andmeet deadlines.● Responsible for execution of Airflow Visualization Studies to satisfy regulatory requirements for airflow profilesin aseptic (Grade A/Class 100) areas.