Principal Packaging & Device Assembly Engineer
INCOG BioPharma ServicesFishers, Indiana, United States
Posted November 5, 2025
Full Time
About the Company
INCOG BioPharma Services specializes in injectable drug product formulation development, analytical method development, process scale-up, and formulation & filling of vials, syringes, and cartridges. The company also offers customized packaging services including labeling, device assembly, final packaging, and integrated storage solutions at various temperature conditions. INCOG's expertise lies in providing comprehensive pharmaceutical solutions that meet the highest quality standards.
Job Description
The Technical Services and Manufacturing Sciences (TSMS) Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.
Requirements
- Execution of early packaging and/or device assembly development activities in a cross-functional team
- Meet with client team to understand packaging requirements and develop technical documentation
- Solid understanding of combination devices (auto injectors), packaging materials and manufacturing processes
- Leadership in technical troubleshooting and investigations of packaging issues
- Provide technical guidance and oversight to Operations and Validation group
- Author and review of regulatory information packages and filings/submissions
- Demonstrate ability to engage and effectively influence team members
- Monitor Process Data, identify trends and propose actions