CQV Engineer

Title: CQV Engineer – Large-Scale Cell Culture FacilityLocation: Devens, MADuration: 4+ Months Schedule: 2-10PM Mon-Friday (Overtime will most likely be available)Role:CQV resources supporting an NPD large-cap project modifying existing equipment and processes for future methods in an existing large-scale cell culture facilityFocus on process equipment on the floor, walking systems down, and executing qualifications and related documentationAll 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 shiftHands-on execution of IQ and OQ and traditional qualification activities, including:Walking drawings down and verifying against field configurationTOPs for materials certificationsVerifying maintenance systems are activeVerifying process flow paths and operation per functional designWet testingSIP/CIP cycle development for flow paths in coordination with manufacturing engineeringPost-IQ/OQ activities:Steam-in-place temperature mappingBI (biological indicator) training and retrievalPulling process data and working with QC lab reportsGenerating, executing, and reporting on validation documentation in ValGenesisExperience / comfort working with:Large-scale cell culture (20kL bioreactor; batches 8–16kL)Downstream equipment: harvest clarification, viral filtration, ultrafiltration, buffer transfer, tank farms, chromatographySteam clean-in-place activitiesStrong GDP and project timeline execution; ability to support compressed schedule with 2–3 shift coverageNo CSV or lab validation required (process/CQV focus only)