Senior Quality Engineer

Simtra BioPharma Solutions

Bloomington, Indiana, United States
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Validation strategy and processes
Quality systems assessment
Pharmaceutical drug products
** Simtra BioPharma Solutions is seeking a Senior Quality Engineer to oversee quality assurance processes in their pharmaceutical manufacturing operations in Bloomington, Indiana. The ideal candidate should have a background in engineering, preferably within the pharmaceutical industry, and possess strong technical knowledge related to validation processes. **

Job Summary

  • The Senior Quality Engineer is responsible for Quality oversight and approvals for Change Control, Requirements, Technical Specifications, Design Specifications, and Validation protocols.
  • Responsibilities include providing guidance and technical expertise in validation strategy, approving change documentation and protocols (FAT, SAT, IQ, OQ), and conducting assessments of quality systems.
  • Simtra BioPharma Solutions offers comprehensive benefits including medical, dental, 401(k) with company match, and a robust time off program.

Matching Summary

Match Score: 75

** Simtra BioPharma Solutions is seeking a Senior Quality Engineer to oversee quality assurance processes in their pharmaceutical manufacturing operations in Bloomington, Indiana. The ideal candidate should have a background in engineering, preferably within the pharmaceutical industry, and possess strong technical knowledge related to validation processes. **

Skills & Requirements

Must-have

  • validation strategy and processes
  • quality systems assessment
  • pharmaceutical drug products
  • aseptic manufacturing environment
  • critical thinking and decision making

Nice-to-have

  • growth mindset
  • respecting each voice
  • taking pride in work
  • cost saving ideas
  • facility improvements

Key Requirements

  • Bachelors’ degree in Engineering
  • 3 years engineering experience
  • Quality Engineer certification preferred
  • Prior experience in aseptic manufacturing

Work Rights

Not specified

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