BD · 2 months ago
Equipment Validation Engineer - North America
USA NE - Columbus (West)
Full-time
Onsite
Senior Level
5+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing the world of health. The Equipment Validation Engineer will manage the integration and implementation of equipment and processes at BD production sites, ensuring efficiency and compliance with quality standards.
Health CareMedical DeviceTechnical Support
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
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
Qualification
Required
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
Benefits
Access a portion of your pay before pay day with DailyPay
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)
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
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