Lead CQV Engineer

Piper Companies is hiring a skilled Lead CQV Engineer for an onsite, contract position based out of Lebanon, IN. The Lead CQV Engineer will be responsible for lead commissioning, qualification, and validation (CQV) efforts for a greenfield API manufacturing project, focusing on downstream purification systems and critical utilities.

Responsibilities of the Lead CQV Engineer:

• Lead CQV activities for a greenfield API manufacturing facility, focusing on downstream purification systems and associated skids.
• Oversee commissioning and qualification of utility systems including WFI, glycol, solvents, and process gases.
• Collaborate with cross-functional teams to ensure timely execution of project milestones and compliance with regulatory standards.
• Develop and review CQV documentation, including protocols, reports, and risk assessments.
• Provide technical leadership and mentorship to junior engineers and support staff throughout the project lifecycle.

Qualifications for the Lead CQV Engineer:

• 7–8 years of experience in API process systems and utility CQV, with a strong background in downstream/purification technologies.
• Proven track record of leading large-scale capital projects, preferably in greenfield environments.
• Bachelor’s degree in engineering or a related technical discipline; advanced degree or certifications in CQV or GMP compliance are a plus.
• In-depth knowledge of industry standards, regulatory requirements, and best practices in pharmaceutical CQV.
• Strong communication, organizational, and leadership skills, with the ability to work effectively in a team-oriented environment.

Compensation for the Lead CQV Engineer:

• Salary: $124,000-$130,000 USD/year
• Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 12/1/25. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CQV Engineer, API process, downstream purification, chromatography, skids, utilities CQV, WFI systems, glycol systems, solvent handling, process gases, greenfield project, large capital project, pharmaceutical engineering, GMP compliance, commissioning and qualification, validation engineer, biotech manufacturing, process engineering, utility systems, pharmaceutical CQV, engineering project lead

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