CQV Engineer

• 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.
• All 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.
• Experience / comfort working with:
• Large-scale cell culture (20kL bioreactor; batches 8 16kL).
• Downstream equipment: harvest clarification, viral filtration, ultrafiltration, buffer transfer, tank farms, chromatography.
• Steam clean-in-place activities.
• Strong GDP and project timeline execution; ability to support compressed schedule with 2 3 shift coverage.
• No CSV or lab validation required (process/CQV focus only).