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Senior Process Engineer - Containment

Indianapolis $120,000 - $150,000 Permanent

Job Responsibilities:

  • Provide technical leadership for isolator and containment process engineering activities across sterile manufacturing.
  • Assess and approve process and equipment changes, ensuring regulatory and quality compliance.
  • Lead risk assessments, process FMEAs, and validation activities for aseptic and containment systems.
  • Investigate and resolve process and equipment issues using structured root cause methodologies.
  • Develop and execute engineering studies, process validation strategies, and technical documentation.
  • Collaborate with automation, quality, manufacturing, and external vendors to support lifecycle management and continuous improvement.
  • Mentor junior engineers and contribute to cross-functional technical teams.


Job Qualifications:

  • BS or higher in Engineering or related technical discipline.
  • 7+ years in a regulated manufacturing environment (biopharma, sterile injectables, or similar).
  • Experience with aseptic processing, isolators, containment systems, or sterile manufacturing technologies.
  • Strong technical writing, investigation, and cross-functional leadership skills.
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