CQV Engineer

CQV Engineer at Intellectt, Inc CQV Engineer at Intellectt, Inc in Still River, Massachusetts Posted in about 6 hours ago.

Type:

full-time

Job Description:

Title:

CQV Engineer (Second Shift)

Location:

Devens, MA Duration:

03-04+ months Pay rate: $32/hr -$37/hr on W2

Role:

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. Our client is working within an existing GMP facility and has a 3 month window where nonGMP activities are occurring. New equipment is coming in Mid June over the course of a few weeks that all needs to be validated. All protocols are already written in ValGensis and our client needs 5 resources to execute those protocols. Downstream equipment validation execution experience in Biologics is required and each candidate will have ideally 4-7 years of experience. Equipment includes but is not limited to harvest clarification equipment, viral filtration equipment, ultra filtration equipment, buffer transfer equipment, tank farms, and chromatography. These resources will not be writing validations, strictly executing.

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)