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CQV Engineer Katalyst Healthcares & Life Sciences - 4.0 Bellevue, NE Job Details Contract 19 hours ago Qualifications Laboratory equipment performance testing and validation Biochemical laboratory techniques Production validation processes

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. 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).