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CQV Engineer

Job Description:ย Position is primarily responsible for developing, executing, and documenting commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified pharmaceutical manufacturing equipment, utilities, and facilities.Position will also be responsible for authoring and reviewing qualification documents, test scripts, deviation reports, summary reports, and supporting risk-based CQV activities in compliance with FDA, EMA, GMP, and internal quality standards.Position will be in charge of collaborating cross-functionally with engineering, quality, validation, and manufacturing teams while supporting facility startup, expansion, technology transfer, process validation, deviation investigations, CAPA activities, and continuous improvement initiatives throughout the CQV lifecycle.ย Qualifications:3+ years of CQV / Validation Engineering experience within pharmaceutical, biotech, or medical device manufacturing environments is required!Hands-on IQ/OQ/PQ protocol authoring and execution experience is required!Experience supporting GMP manufacturing systems such as bioreactors, HVAC, clean utilities, process skids, packaging/fill-finish equipment, or lab systems is required!Experience supporting facility startup, expansion, or technology transfer projects is preferred!Familiarity with validation systems and tools such as Kneat, ValGenesis, TrackWise, SAP, DeltaV, SCADA, or BMS is preferred!๐…๐จ๐ซ๐ฐ๐š๐ซ๐ ๐ฒ๐จ๐ฎ๐ซ ๐ฎ๐ฉ๐๐š๐ญ๐ž๐ ๐‘๐ž๐ฌ๐ฎ๐ฆ๐ž ๐ญ๐จ: kavya@fuera.ai