Lead Process Development Engineer

Aprecia Pharmaceuticals - Cincinnati, OH

Full-time - Mid Level

Cincinnati, OH

Merchant Wholesalers, Nondurable Goods

About the position

The position involves filling a key role on a team of engineers and scientists focused on the innovation and development of proprietary and non-proprietary processes and technologies for the pharmaceutical industry, particularly utilizing additive manufacturing platforms. The role is responsible for supporting the engineering and development of innovative technologies, equipment, and processes, ensuring that pharmaceutical product developers have a comprehensive toolset for developing commercially viable products. The individual will provide process expertise for the design, development, installation, and validation of Aprecia's proprietary 3D printing technology platforms, while also expanding and supporting the technology platforms used in product development programs.

Responsibilities

• Become an operational SME (subject matter expert) on Aprecia's next generation and legacy 3DP manufacturing equipment.
• Coordinate and lead activities regarding the development of automated equipment and processes, including developing operational and in-process testing concepts and supporting documentation.
• Work directly with Product Development, Technical Services, and Manufacturing colleagues to ensure processes meet performance, flexibility, ruggedness, reproducibility, and cost efficiency expectations.
• Operate laboratory equipment to develop new printing fluids and product material characterization.
• Collaborate with technology and integration vendors to ensure projects meet specifications and are delivered on time.
• Oversee collection and statistical evaluation of process data to support new equipment capabilities and critical process parameters for continuous improvement.
• Author and review technical memos, qualification/validation protocols, and reports for drug product manufacture.
• Execute sampling and testing based on protocols to support validation activities.
• Prepare or review documentation including change control documentation and operation/maintenance manuals for qualified equipment.
• Manage projects for technical transfer and continuous improvement efforts.

Requirements

• B.S. degree in Engineering, Chemistry, Math or a related discipline required.
• Minimum 5-10 years of experience in the pharmaceutical or additive manufacturing industry.
• Experience in technology development from proof-of-concept to production scale implementation required.
• Hands-on experience operating, troubleshooting, testing, and improving manufacturing equipment required.
• Working knowledge of the pharmaceutical industry and cGMPs preferred.
• Strong written, verbal, and interpersonal skills.
• Statistical analysis, data management, and data visualization skills.

Nice-to-haves

• M.S. degree in Engineering, Chemistry, Math or a related discipline desired.
• Experience with structured problem-solving tools and leading multi-disciplinary teams.
• Binder-Jet/Inkjet printing technology operational/troubleshooting experience desired.
• Powder bed additive manufacturing operational/troubleshooting experience desired.
• Project management and/or vendor management experience desired.
• Mechanical/electrical assembly, wiring, and troubleshooting capability a bonus.
• Machining/fabrication/welding skills a bonus.
• PLC/Controls/Programming skills a bonus.

Benefits

• Health insurance coverage
• 401k benefit for retirement savings plan
• Paid holidays
• Flexible scheduling options