What are the responsibilities and job description for the CQV Engineer position at Katalyst Healthcares & Life Sciences?
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).