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Lead CQV Engineer (Lebanon, IN)
Lead CQV Engineer (Lebanon, IN)Piper Companies • Indianapolis, IN, US
Lead CQV Engineer (Lebanon, IN)

Lead CQV Engineer (Lebanon, IN)

Piper Companies • Indianapolis, IN, US
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Overview

Join to apply for the Lead CQV Engineer (Lebanon, IN) role at Piper Companies . The Lead CQV engineer will be onsite in Lebanon, IN. Piper Companies is searching for an experienced CQV Engineer to manage the commissioning, qualification and validation of equipment, systems, and processes to meet regulatory standards.

Responsibilities for the Lead CQV Engineer include :

Responsibilities

  • 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.

Qualifications

  • 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

  • Salary : $120,000 / year - $140,000 / year based on experience
  • Comprehensive benefits : Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

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