Equipment Validation Engineer - North America

Becton Dickinson Medical Devices•Columbus, OH

12d

About The Position

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. Develops Strategies, Collaborates and Communicates with: Program Managers: To ensure that the integrated equipment / processes are delivered on time/within budget and to required quality standards. Quality Team: To ensure that the integrated equipment / processes meet necessary quality / regulatory standards. Manufacturing & Operations Team: To ensure that the integrated equipment / processes are easy to operate, maintain, reliable and that equipment is operating efficiently / effectively from handover / hyper care to meet production targets. Suppliers and Vendors: To source and integrate equipment technologies while ensuring project milestones are met. Equipment Design Team: To ensure that equipment is designed, built, and tested to meet production requirements. Finance team: For CapEx spending reporting. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

Bachelor's degree in Engineering (Electrical, Mechanical, Controls, Automation) or Project Management, preferred.
5 years of progressively responsible engineering and project management experience.
Extensive experience in integrating equipment within complex manufacturing sites with a strong focus on validation and vertical start up.
Proven lean leadership experience who can assimilate data in a structured manner and present recommendations based on facts and data.
Proven leadership in project and capital management.
Exceptional communication and presentation skills.
Ability to travel up to 50% of the time

Responsibilities

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 CapEx 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.
Specific Process Equipment 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.
Leading KPI 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 Lagging KPI 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 the next survey point (GIE Pulse)

Benefits

Competitive pay
Access a portion of your pay before pay day with DailyPay
Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%. Dental and vision insurance at group rates.
Paid parental leave up to 6 weeks
Adoption assistance plan
401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation
Company paid basic life and AD&D insurance
Tuition reimbursement
Discounted home, auto and pet insurance
Paid holidays and vacation (pro-rated the first year based on actual start date)