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...