CQV Engineer

Piper Companies is seeking a CQV Engineer for an organization dedicated to providing operational readiness for biotech leaders. The ideal candidate will have extensive experience with aseptic fill lines and is able to work independently. This position will be full on-site in Indianapolis, Indiana (IN).

Responsibilities of the CQV Engineer:

• Develop and update user requirement specifications, traceability matrices, and design documentation.
• Author IOQ protocols and support PQ planning and execution.
• Perform ongoing assessments and support test reference integration.
• Coordinate with vendors and cross-functional teams including QA and process engineering.
• Support commissioning and qualification activities for aseptic fill lines and related equipment.

Qualifications for the CQV Engineer:

• 5+ years of experience in pharmaceutical manufacturing.
• 2+ years of experience working on aseptic fill lines.
• Well-rounded with manufacturing equipment such as tanks, autoclaves, etc.
• Strong understanding of protocol generation and ability to execute clear documentation.
• Bachelor's degree in engineering, chemistry, or related field.

Compensation for the CQV Engineer:

• Salary Range: $114,000-124,000/year
• Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

This job opens for applications on 10/27/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CQV, CQV engineer, aseptic fill lines, aseptic, IQ, OQ, PQ, documentation, tanks, autoclaves, traceability updates, commissioning, qualification, validation, IOQ, traceability matrix, protocol development, GMP, technical writing, cleanroom, vendor coordination, pharmaceutical manufacturing, equipment validation.

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