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 using document management systems like KNEAT or Veeva.
- Lead or support commissioning, qualification, and validation (CQV) activities, ensuring successful tech transfer and regulatory compliance for equipment and processes.
Required:
- Doctorate degree (no experience required) OR Master's degree plus 2 years of GMP experience OR Bachelor's degree plus 4 years of GMP experience OR Associate's degree plus 8 years of GMP experience OR High school diploma/GED plus 10 years of GMP experience.
- Strong, hands-on experience within GMP-regulated environments and direct experience with packaging or device assembly equipment (automated or semi-automated), with involvement in commissioning, qualification, and validation (CQV).
- Proven ability to author and manage GMP documentation, including protocols, reports, and validation documents, with experience in document management systems (preferably KNEAT or Veeva) and ownership of deviations, CAPAs, and change controls.
- Demonstrated skills in analyzing and optimizing manufacturing processes, driving efficiency and performance improvements, and providing technical leadership in process and equipment optimization.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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