Equipment Validation Engineer III

Overview

Job Description

Summary:

The role of Global Integrated Engineering is to support all BD manufacturing sites globally in their capital deployment of “break-through” and capacity / replacement programs to meet business growth needs. The role is to drive the integration and manage the end-to-end implementation of process and equipment at BD appointed production sites working in partnership with the sites for a seamless transition and rapid startup.

• Participate at FAT and SAT with EDE team.
• Prepare an installation plan and full validation of equipment.
• Manage the integration of new equipment validation, and vertical start-up into the existing manufacturing process ensuring the training plan and competence assessments are completed.
• Ensure minimal disruption to ongoing operations during equipment or software integration, addressing any issues or roadblocks.
• Support the documentation of equipment instruction and process parameters and support the site for training on the new equipment and application.
• During the ramp up phase, provide ongoing technical assistance during the ramp up phase to support maintaining long term capability, OEE target and CI initiatives.
• Consolidate opportunities identification to improve integration processes, tools methodologies, staying current with industry best practices and emerging technologies.
• Ensure equipment and installation conforms to Environmental Health and Safety, international standards and company policies to include lock-out tag-out, controls, guarding, etc.
• Measure and oversee performance on the operability of the equipment, ensuring optimal performance, minimizing downtime.
• Oversee existing tools and resources needed to support equipment maintenance programs, center lining procedures, and to ensure reliability and up-time.
• Coordinate the handover to other departments (i.e. operations/maintenance/quality) to ensure smooth production ramp-up / alignment with overall company objectives.
• Manage adherence to production ramp-up plans to ensure that newly installed equipment meets performance targets.
• Ensure all gaps between expected and actual performance of new Cap Ex integration during the ramp up phase.
• Resolve integration plans and schedules which covered of resources, timeline, and key milestones.
• Execute test plans to verify functionality, process windows, performance, and reliability of equipment (i.e. FAT, SAT, Validation, Commissioning, etc.).
• Perform center lining of equipment to optimize the equipment performance.
• Execute the diagnoses and resolution of integration issues, working closely with respective engineering teams or vendors to identify root causes and implement corrective actions.
• Perform equipment documentation, including document creation, data compilation & document hand-over, in terms of equipment architecture diagram, specifications, test reports, maintenance and control plans.
• Support collaboration with various engineering teams or vendors (i.e. mechanical / electrical / software) to ensure smooth integration of respective equipment, subsystems, and components.

• Lead team in problem solving – identification of Equipment & Automated Systems problems and analysis of the root cause.
• Troubleshoot Equipment systems processes and material or equipment issues through scientific approaches and tools.
• Support Proof of Concept (POC) evaluation and Design Of Experiments (DOE), establish baseline process and metrics for Equipment & Automated Systems.
• Verify a relationship between Equipment & Automated Systems Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs).
• Responsible for execution of process verification, process validation and production ramp-up activities for Equipment & Automated Systems.

• Accountable for Integration lead time reduction (Time): 10% on Focus lines / 30% on New lines
• Accountable for Improved equipment performance (OEE) through validation: +10% vs Focus M/c's / >82% @ on New Line

• Accountable for # of accidents attributable to the introduction of new capital equipment by GIE
• Drive GIE VoA Index Improvement vs. ISC Baseline (72 Org Commitment) measured at…