Process Engineer

2 weeks ago

Indianapolis, Indiana, United States Harba Solutions Inc. Full time $80,000 - $120,000 per year

Responsibilities

  • Lead the scale-up and transfer of manufacturing processes from development to full-scale production, using internal data or client-provided information.
  • Select suitable equipment and single-use systems for GMP manufacturing and prepare supporting technical documentation, including transfer plans, gap assessments, process flow diagrams, reports, and risk analyses (e.g., FMEAs).
  • Serve as a technical expert for assigned manufacturing processes, representing the technical support team on project teams and in client discussions.
  • Author and review GMP documentation such as master batch records, bills of materials, and processing forms.
  • Monitor process performance data, identify trends, and recommend corrective or optimization actions.
  • Lead or support technical troubleshooting and investigations to determine root causes, assess product impact, and implement effective CAPAs.
  • Provide guidance to operations, validation, and other functional teams during process qualification and ongoing process verification activities.
  • Collaborate cross-functionally to evaluate and introduce new technologies into GMP manufacturing.
  • Assess and document the impact of changes related to products, processes, equipment, materials, or procedures.
  • Manage multiple projects simultaneously, prioritize critical tasks, and ensure deadlines are met.
  • Perform other duties as assigned to support manufacturing and process improvement initiatives.

Qualifications

  • Bachelor's degree in Science or Engineering required; Master's degree preferred.
  • 1–3 years of GMP manufacturing experience in the pharmaceutical, biotech, or related regulated industry.
  • Hands-on experience with process transfer or technical transfer activities.
  • Strong understanding of process development, equipment selection, and GMP documentation.
  • Demonstrated ability to analyze data, identify trends, and drive process improvements.
  • Excellent communication, problem-solving, and project management skills.
  • Ability to work collaboratively across functional teams in a fast-paced, dynamic environment.

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