5-7 years of CQV experience, particularly with process equipment in a biomanufacturing setting.
Strong background in executing IQ and OQ qualification activities.
Experience with large-scale cell culture systems, particularly 20kL bioreactors.
Demonstrated ability to generate and execute validation documentation in ValGenesis.
Comfortable with downstream processes and associated equipment including harvest clarification and chromatography.
Responsibilities
Support CQV activities for a large-cap NPD project in a large-scale cell culture facility.
Execute qualifications and related documentation focusing on process equipment.
Utilize ValGenesis for validation documentation and execution.
Walk down and verify equipment diagrams against actual configurations.
Conduct wet testing and develop SIP/CIP cycles under manufacturing engineering guidance.
Benefits
Work in a cutting-edge biomanufacturing environment.
Collaborative second-shift team structure fostering independence yet ensuring support.
Engage with large-scale and complex bioprocessing systems.
Opportunity to lead and support compressed project schedules.
Full Job Description
Responsibilities:
CQV resources supporting an NPD large-cap project modifying existing equipment and processes for future methods in an existing large-scale cell culture facility.
Focus on process equipment on the floor, walking systems down, and executing qualifications and related documentation.
ll validation documentation and execution in ValGenesis (e-validation platform), including one documentation-focused resource.
Most Important Skills Needed:
Strong CQV experience with process equipment; able to work independently, set their own pace and goals, and still maintain team structure on second shift.
Hands-on execution of IQ and OQ and traditional qualification activities, including:
Walking drawings down and verifying against field configuration.
TOPs for materials certifications.
Verifying maintenance systems are active.
Verifying process flow paths and operation per functional design.
Wet testing.
SIP/CIP cycle development for flow paths in coordination with manufacturing engineering.
Post-IQ/OQ activities:
Steam-in-place temperature mapping.
BI (biological indicator) training and retrieval.
Pulling process data and working with QC lab reports.
Generating, executing, and reporting on validation documentation in ValGenesis.
