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.