Katalyst CRO

Process Validation Engineer

about 1 month ago

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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.

Requirements:

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.