CQV Engineer - Pharma

Job Title: CQV Engineer - Pharma Location: Devens, MA Duration: 6 - 12 Months Position Overview: Our client is seeking CQV Engineers to support an NPD large-cap project involving modification of existing equipment and processes for future methods within an existing large-scale cell culture facility. These resources will focus on process equipment qualification execution, including walking systems down, executing qualification protocols. Key Responsibilities: Execute IQ/OQ and traditional qualification protocols for process equipment Perform field walkdowns and verify drawings against installed configurations Verify maintenance systems, process flow paths, and functional design requirements Execute wet testing and operational verification activities Support SIP/CIP cycle development in coordination with Manufacturing Engineering Perform post-IQ/OQ qualification activities including: Steam-in-place temperature mapping Biological Indicator (BI) placement/retrieval Process data collection and QC lab report coordination Generate, execute, and report validation documentation inValGenesis Support compressed project timelines across multi-shift execution schedules Required Qualifications: Strong CQV / Validation Execution experience with process equipment Hands-on experience executing IQ/OQ protocols Ability to work independently while maintaining alignment with team/project goals Experience with ValGenesis or similar e-validation platforms Strong GDP/documentation practices Required Technical Experience: Downstream biologics equipment qualification/validation execution experience Experience with: Harvest Clarification Equipment, Viral Filtration Equipment, Ultrafiltration Systems, Buffer Transfer Equipment, Tank Farms, Chromatography Systems, Steam Clean-in-Place / SIP / CIP activities, Large-scale biologics/cell culture manufacturing environments Preferred Background: 4–7 years of relevant CQV/Validation experience Experience in large-scale biologics manufacturing Prior work in GMP cell culture facilities