Piper Companies is seeking a Lead CQV Engineer for an team advancing pharma manufacturing through technical consulting located in Indianapolis, Indiana (IN). The ideal Lead CQV Engineer will have experience working with all inputs related to protocol development, air flow testing, and some cleaning validation. This is an on-site position in Indianapolis, IN.

Responsibilities of the Lead 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, leveraging a strong understanding of system requirements.

Qualifications for the Lead CQV Engineer:

• Proven experience with commissioning, qualification, and validation (CQV) processes in a GMP-regulated environment.
• Strong understanding of IOQ protocol development, execution, and component-level assessments.
• Ability to work cross-functionally with QA, engineering, and external vendors.
• 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.
• Comfortable working onsite in a fast-paced, hands-on environment with minimal supervision.

• 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, leveraging a strong understanding of system requirements