CQV Engineer

Job-ID Reference 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).