EDI Staff Engineer Job Columbus area,Nebraska USA,Engineering

Responsibilities

Develops Strategies, Collaborates and Communicates with the following teams:

Product Design Team:
Support manufacturable product designs aligned with cost and quality targets.
Unit and Plant Quality Teams:
Support compliance with regulatory, GMP, ISO, and validation requirements.
Production Teams:
Ensure equipment is operable, reliable, and capable of meeting production targets.
Maintenance / Engineering Teams:
Support uptime, maintainability, and troubleshooting readiness.
Procurement & Vendors:
Support sourcing, supplier technical alignment, and execution milestones.
Plant Quality Team:
Ensure equipment is operating within specified tolerances and products meet required quality & regulatory standards.
Program Management:
Support delivery of equipment and automation scope on time and within budget.
Finance Team:
Support Cap Ex tracking and reporting.

RESPONSIBILITIES

Process & Equipment Design and Development

Support design and development of assembly, packaging, automation, inspection, and manufacturing equipment including mechanical, electrical, and control elements.
Support preparation, maintenance, and execution of User Requirement Specifications (URS).
Support evaluation of technical concepts considering risk, scalability, validation impact, cost, and lifecycle requirements.
Participate in design reviews, machine safety reviews, risk assessments, and FMEA activities.
Lead Proof of Concept (POC) evaluations and Design of Experiments (DOE).
Verify relationships between Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs).
Develop center lining activities to optimize equipment performance.
Identify opportunities to improve equipment operability, ergonomics, maintainability, reliability, and cost of ownership.
Lead and support problem solving activities related to Equipment & Automated Systems.
Troubleshoot equipment systems, materials, or process issues using scientific approaches.
Lead and support POC evaluation and DOE to establish baseline processes and metrics.

Supplier & Capital Project Support

Equipment Integration, Installation, Validation & Start-Up

Support execution of equipment installation plans and site readiness activities.
Execute and support qualification, process verification, and process validation activities.
Support vertical start-up and production ramp-up activities.
Minimize disruption to ongoing operations during equipment or automation integration.
Troubleshoot equipment and automation issues using structured problem‑solving tools.
Execute process verification and production ramp-up activities for Equipment & Automated Systems.

Ramp‑Up, Performance & Continuous Improvement

Provide technical support during ramp-up to achieve OEE, yield, throughput, and reliability targets.
Measure and analyze gaps between expected and actual performance.
Lead continuous improvement and Lean Manufacturing initiatives.

Documentation, Training & Handover

Support creation and handover of equipment documentation including specifications, drawings, FAT/SAT, validation, maintenance and control plans.
Support preparation of operating instructions and troubleshooting documentation.
Support training of site personnel on new equipment and processes.
Support formal handover to Operations, Maintenance, Engineering, and Quality teams.

Compliance, Safety & Quality

Ensure compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements.
Support internal and external audits, inspections, and regulatory interactions.

Performance Indicators (Accountability)