Piper Companies
Piper Companies is seeking a Filling CQV Engineer for an team advancing pharma manufacturing through technical consulting located in Indianapolis, Indiana (IN) . The ideal 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 Filling CQV Engineer :
This job opens for applications on 08/06/2025. 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,
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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, leveraging a strong understanding of system requirements.
- 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.
- 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.
- Bachelor's degree in an engineering field.
This job opens for applications on 08/06/2025. 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,
#LI-GP2 #LI-ONSITE