CQV Engineer

Katalyst CRO; Bellevue (NE); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Bellevue, NE is seeking CQV resources to support an NPD large-cap project that modifies existing equipment and processes for future methods in an existing large-scale cell culture facility. The role focuses on process equipment on the floor, walking systems down, and performing qualifications with related documentation.

Candidates should have strong CQV experience with process equipment, be able to work independently with shift coverage, and execute IQ/OQ activities including

Qualifications

• Strong CQV experience with process equipment; able to work independently, set pace and goals, while maintaining team structure on second shift.
• Hands-on execution of IQ and OQ and traditional qualification activities.
• Walking drawings down and verifying against field configuration.
• Steam-in-place? (SIP) cycle development for flow paths.

Responsibilities

• Support an NPD large-cap project modifying existing equipment and processes for future methods in a large-scale cell culture facility.
• Focus on process equipment on the floor, walking systems down, and executing qualifications and related documentation.
• Generate, execute, and report validation documentation in ValGenesis.

Skills

CQV experience

Process equipment

IQ/OQ execution

ValGenesis

Documentation

GDP

Shift coverage

Bioreactor ops

Downstream equipment

Wet testing

Tools

ValGenesis

Job description

• 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.

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 816kL).
• 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 23 shift coverage.
• No CSV or lab validation required (process/CQV focus only).