CQV Engineer

Overview

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

• Execute Installation and Operational Qualification (IOQ) protocols for an 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.

• 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.

• $75,000 - $100,000
• Comprehensive benefits:
  Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

#LI-BH1

#LI-ONSITE