Senior Engineer
$31,200–$31,200 year
On-siteThousand Oaks, California, United States or Juncos, Juncos, Puerto Rico
Job Summary
Lead visual inspection technical strategy and troubleshooting for biologics drug product development, filling, and finish processes. Establish testing strategies, characterization protocols, and offline methods for pipeline and commercial products while leveraging AI, LLMs, and in silico modeling to accelerate R&D and testing. Execute and document laboratory studies, conduct root cause analysis for non-conformances, and manage defect kit preparation. Collaborate with cross-functional teams to develop lean study designs, implement data acquisition tools, and align operational efficiency across manufacturing sites. Perform risk assessments, develop validation plans, and ensure compliance with FDA and international standards. Travel up to 10% domestically and internationally to support site capabilities and best practices.
Required Qualifications
- Doctorate Degree OR Master's Degree and 2 years of Engineering and/or Operations experience OR Bachelor's Degree and 4 years of Engineering and/or Operations experience OR Associate's degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 10 years of Engineering and/or Operations experience
- PhD with 2 years of industry experience
- Background industry with development and manufacturing visual inspection experience
- Experience with Knapp studies
- Experience in packaging and inspection equipment
- Previous experience with Pharma inspection background
- up to 10% travel to domestic and international sites
Desired Qualifications
- Experience with generative AI
- Experience with large language models (LLMs)
- Experience with in silico modeling
- Experience with advanced statistical/analytical techniques
- Proficiency in statistical analysis software
- Experience with advanced AI technologies
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.