CQV Engineer

Piper Companies is seeking a CQV Engineer who will responsible for commissioning, qualifying and validating equipment, systems, and processes to meet regulatory standards. The CQV engineer will be onsite in Indianapolis, IN.

Responsibilities for the CQV Engineer include:

·       Execute Installation and Operational Qualification (IOQ) protocols for a Aseptic Filler system.

·       Perform airflow testing and support potential design qualification activities.

·       Collaborate with project teams to ensure compliance with CQV standards in a parenteral manufacturing environment.

·       Support documentation and reporting of qualification activities, with Performance Qualification (PQ) potentially added to scope.

Requirements for the CQV Engineer include:

·       Perform IOQ execution, airflow testing, and support design qualification in a parenteral manufacturing environment.

·       Apply CQV principles to ensure equipment meets regulatory and operational standards, with potential involvement in future PQ activities.

·       Collaborate with cross-functional teams to troubleshoot issues and maintain compliance throughout the commissioning process.

·       Utilize technical documentation and validation protocols to support project deliverables and ensure traceability.

·       Requires skills in GMP compliance, aseptic processing, technical writing, problem-solving, and familiarity with pharmaceutical manufacturing systems.

Compensation for the CQV Engineer includes:

·       $75,000 - $100,000

·       Comprehensive benefits: Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

Keywords: CQV engineer, qualification, IQ, OQ, PQ, validation, GMP, good manufacturing practices, cGMP compliance, FDA regulation, ISO standards, quality system regulation, QSR, risk assessment, equipment validation, process validation, cleanroom protocols, automation system, calibration, trackwise, problem solving, technical writing, communication, adaptability, time management

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This job is open for applications on 8/8/2025. Applications for this job will be accepted for at least 30 days from the posting date