Idm Ts/ms Product Steward (r2-r3)

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

Develops product and process improvements for a regulated manufacturing environment, focusing on design control, validation, verification, and manufacturing control strategy. Responsibilities include developing specifications, protocols, and technical reports, supporting product lifecycle management, leading FMEA and root cause investigations, and participating in design reviews. Requires experience in technical services/manufacturing sciences within a regulated setting, CAD software, continuous improvement, analytical evaluations, device platforms, and drug product/medical device regulatory requirements.

What you'd actually do

  1. Responsible for design control, validation and verification activities, and manufacturing control strategy.
  2. Develop specifications, protocols, sampling plans, engineering studies, and technical reports.
  3. Provide support to product lifecycle management and monitoring processes.
  4. Organize and facilitate Failure Modes, and Effects Analysis (FMEA) meetings and lead on multi-functional project teams.
  5. Lead root cause investigation team to develop and implement corrective and preventative actions.

Skills

Required

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering field
  • 3 years of experience working in technical services/manufacturing sciences, engineering, quality, development, or manufacturing/packaging in a regulated manufacturing operations environment
  • 3 years of experience working 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 associated with products, test systems, and analytical methods
  • 3 years of experience working with device platforms, including design, materials of constructions, manufacturing process, and quality systems
  • 3 years of experience working with Primary Loop, Operational Excellence, and Root Cause Analysis
  • 3 years of experience working with drug product and medical device regulatory requirements, including cGMP, 21 CFR 820,ISO 13485, and ISO11608

What the JD emphasized

  • regulated manufacturing operations environment
  • drug product and medical device regulatory requirements, including cGMP, 21 CFR 820,ISO 13485, and ISO11608