Piper Companies is searching for an experienced Filling CQV Engineer to join a team of engineering consultants focused on advancing pharmaceutical manufacturing through technical expertise and consulting. The ideal CQV Engineer will have experience working with all inputs related to protocol development, air flow testing, and cleaning validation. This is an on-site position in Indianapolis, IN.

Responsibilities of the Filling CQV Engineer:

• Develop and execute IOQ protocols for isolator filling systems and related equipment.
• Collaborate with QA, vendors, and design teams to resolve design issues and implement upgrades.
• Conduct component-level assessments and support airflow testing activities.
• Work independently onsite to troubleshoot equipment and ensure compliance with user and regulatory requirements.
• Support ongoing commissioning and qualification efforts, including potential design qualification.
• Contribute to protocol development with minimal oversight.

Qualifications for the Filling CQV Engineer:

• 5+ years of experience with commissioning, qualification, and validation (CQV) processes in a GMP-regulated environment.
• Strong understanding of IOQ protocol development, execution, and component-level assessments.
• Familiarity with isolator filling systems and cleanroom equipment; airflow testing experience is a plus.
• Self-starter with the ability to manage tasks independently and navigate complex technical challenges.
• Bachelor’s degree in an engineering field.

This job opens for applications on 08/29/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: CQV, Commissioning, Qualification, Validation, IOQ, QA, CV, protocol development, component assessment, isolator filling, airflow testing, equipment qualification, design qualification, GMP compliance, cleanroom systems, cross-functional collaboration, troubleshooting, user requirements, vendor coordination, pharmaceutical manufacturing, installation,

• Develop and execute IOQ protocols for isolator filling systems and related equipment.
• Collaborate with QA, vendors, and design teams to resolve design issues and implement upgrades.
• Conduct component-level assessments and support airflow testing activities.
• Work independently onsite to troubleshoot equipment and ensure compliance with user and regulatory requirements.
• Support ongoing commissioning and qualification efforts, including potential design qualification.
• Contribute to protocol development with minimal oversight