Idm Ts/ms Product Steward (r2-r3)

Eli Lilly UK

Indianapolis, IN, USA
Base: $101,254.00 py; bonus/equity: compyny bonus ...
Design control
Validation and verification
Manufacturing control strategy
Responsible for design control, validation and verification activities, and manufacturing control strategy

Job Summary

  • Responsible for design control, validation and verification activities, and manufacturing control strategy.
  • Organize and facilitate Failure Modes, and Effects Analysis (FMEA) meetings and lead on multi-functional project teams.
  • Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Matching Summary

Responsible for design control, validation and verification activities, and manufacturing control strategy.

Salary

Base: $101,254.00 per year; Bonus/Equity: company bonus (depending, in part, on company and individual performance); Benefits: comprehensive benefit program including 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, time off, well-being benefits.

Skills & Requirements

Must-have

  • design control
  • validation and verification
  • manufacturing control strategy
  • product lifecycle management
  • root cause investigation
  • drug product and medical device regulatory requirements

Nice-to-have

  • unite caring with discovery
  • make life better for people
  • put people first
  • employee resource groups

Key Requirements

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related field
  • 3 years of experience in technical services/manufacturing sciences, engineering, quality, development, or manufacturing/packaging in a regulated manufacturing operations environment
  • 3 years of experience with CAD software packages (Solidworks, ProE, Inventor) and GD&T drawing practices
  • 3 years of experience driving continuous improvement of test systems and validation processes
  • 3 years of experience leading analytical evaluations of events and deviations
  • 3 years of experience with device platforms
  • 3 years of experience with Primary Loop, Operational Excellence, and Root Cause Analysis
  • 3 years of experience with drug product and medical device regulatory requirements, including cGMP, 21 CFR 820, ISO 13485, and ISO11608

Work Rights

Not specified

Tailored Resume

Cover Letter