Title: QAV Engineer
Location: Chicago , IL.
Duration: 12 months
Pay Rate: $45-49/Hr on W2
Position Overview
Our client is a pharmaceutical company seeking a QAV Engineer with a strong Quality background to support the qualification and modernization of an existing manufacturing facility.
The facility is approximately 13 years old and is undergoing a significant revamp, including the introduction of new equipment and updates to existing systems.
The primary focus of this role will be Quality oversight and review of validation activities, ensuring protocols and documentation meet applicable regulatory and site requirements.
Responsibilities
Provide Quality oversight and review of facility, equipment, utility, and process validation activities.
Review, develop, and approve IQ/OQ/PQ protocols and associated validation documentation.
Support QAV activities, ensuring validation work is appropriately documented and compliant with applicable GMP, 21 CFR, and ISO requirements.
Support the Validation Master Plan and overall validation strategy for facility and equipment upgrades.
Review validation documentation, deviations, change controls, and other quality records for compliance and completeness.
Support periodic reviews and ongoing validation activities.
Provide Quality input related to compounding operations, equipment, and facility systems.
Support qualification activities associated with water purification systems and USP Purified Water.
Partner with Quality, Engineering, Manufacturing, and Operations to identify and resolve validation
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