Senior Process Development Engineer

SSi People

📍 New Albany, Ohio, United States

Full-time Engineers

Job Description

Job Title: Senior Process Development Engineer
Location: New Albany, Ohio (On-site)

Job Summary: We are seeking a technical leader to support commercial GMP Final Drug Product operations within an advanced manufacturing environment. Our team is responsible for driving process optimization, supporting automated and semi-automated device assembly, and maintaining rigorous documentation standards in accordance with GMP regulations.


Responsibilities:

  • Provide on-site support for GMP packaging and device assembly operations, including troubleshooting equipment issues and supporting automated/semi-automated lines.
  • Identify and implement process improvements to increase throughput and efficiency, analyze manufacturing data, and drive continuous improvement initiatives.
  • Write, review, and manage GMP documents such as protocols, reports, and procedures, with ownership of deviations, CAPAs, and change controls usi...
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