Process Validation Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Saint Louis, MO 63129
Description:
Responsibilities:
- Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
- Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
- Reviews manufacturing processes, deviations, and/or development and production data.
- Reviews manufacturing batch records, protocols, and control strategies.
- Provide technical support and data analysis for investigations and deviation resolution.
- Recommend changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
- Interact with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.
- Overseas and reports on overall manufacturing progress.
- Bachelor's degree in engineering or science with 8 years of experience.
OR - Master's degree in engineering or science with 5 years of experience.
- Experience in biologics development, bioprocess engineering, technology transfer, and/or commercial manufacturing operations.
- Experience with Good Manufacturing Practices and supporting a commercial facility.
- Experience in cell culture and/or downstream purification (direct lab experience a plus).
- Experience with equipment qualification and process validation.
- Familiarity with formal root cause analysis and/or risk assessment.
- Experience working with statistical analysis software and investigative data analysis.
- Experience with project leadership.
- Experience communicating with cross functional teams.
- Strong technical writing and communication skills.
- Proficient in Microsoft Word, Excel, and PowerPoint.