What are the responsibilities and job description for the CQV Engineer position at Fuera Emerging Technologies Inc?
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.
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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 ๐จ๐ซ๐ฐ๐๐ซ๐ ๐ฒ๐จ๐ฎ๐ซ ๐ฎ๐ฉ๐๐๐ญ๐๐ ๐๐๐ฌ๐ฎ๐ฆ๐ ๐ญ๐จ: kavya@fuera.ai