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Senior Process Engineer II

Indianapolis $130,000 - $160,000 Permanent

Job Responsibilities:

  • Analyze manufacturing data to support continuous process improvements and resolve production issues

  • Lead or support FMEAs to evaluate process and product risks as part of validation efforts

  • Mentor and train team members across engineering and operations functions

  • Ensure successful process validation and comparability by identifying risks, troubleshooting issues, and implementing preventative measures

  • Drive investigations using a structured DMAIC approach to determine root cause and assess operational impact

  • Collaborate with cross-functional teams to support and enhance production activities

  • Evaluate and implement new technologies and automation solutions within GMP manufacturing

  • Develop and maintain technical documentation, including protocols and reports for equipment qualification and process validation

  • Conduct engineering studies, develop manufacturing recipes, and execute validation testing

  • Liaise with vendors to define technical requirements and ensure equipment meets operational needs

  • Adapt to evolving production requirements in a dynamic manufacturing environment

  • Provide flexible support to meet production schedules and operational priorities

Qualifications:

  • Bachelor’s degree or higher in Engineering, Bioengineering, or a related scientific discipline

  • 10+ years of experience in a GxP-regulated manufacturing environment (preferably biopharmaceutical or medical device)

  • Hands-on experience with sterile injectables: formulation, aseptic filling, inspection, and/or packaging

  • Familiarity with data management tools and reliability-centered maintenance (RCM) practices

  • Prior experience in a CMO/CDMO environment preferred

  • Strong technical writing skills for validation protocols, reports, and risk assessments

  • Lean Six Sigma or other technical certifications preferred

  • Electro-mechanical aptitude or practical experience is a plus

  • Proven ability to work both independently and collaboratively in a fast-paced, regulated setting

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