CQV Engineer

Katalyst-Healthcares-; Bellevue (NE); On-site; USD 70,000 - 110,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a CQV-focused professional for an on-site role in Bellevue, NE to support an NPD cell culture facility project. You will work on floor equipment, perform IQ/OQ activities, and manage validation documentation in ValGenesis, ensuring alignment with GDP and project timelines.

Role requires independent work pace with team coordination across 2–3 shifts, and hands-on validation across large-scale bioreactor-related processes.

Qualifications

• Minimum CQV experience with process equipment.
• Ability to execute IQ and OQ qualifications and document results.
• Experience validating field configurations.
• Familiar with GDP and strict project timelines.
• Comfort working with large-scale cell culture equipment.

Responsibilities

• Support CQV resources for an NPD large-cap project modifying existing equipment and processes.
• Focus on floor equipment, walking systems, and qualification execution.
• Generate, execute, and report validation documentation in ValGenesis.

Skills

CQV experience

IQ/OQ execution

ValGenesis documentation

Process equipment focus

Independent with teamwork

2–3 shift coverage

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).