Downstream CQV Engineer - 173962 - 174862 - 175087

Zachary Piper Solutions; Holly Springs (MS); On-site; USD 100,000 - 140,000; Full time

Job summary

Piper Companies is seeking a Downstream CQV Engineer to join a growing biopharmaceutical manufacturing organization in Holly Springs, NC. This onsite, 6-month contract role focuses on commissioning and qualification of downstream systems, utilities, and related equipment across multiple suites.

Responsibilities include executing CQV activities, reviewing drawings and P&IDs, and performing hands-on testing and field walkdowns.

Qualifications

• 2–10 years hands-on CQV/validation experience in large-scale manufacturing.
• Experience with downstream processing equipment; ultrafiltration preferred.
• Mechanical or engineering background with ability to inspect and troubleshoot equipment.
• Familiarity with installation verification, utilities qualification, and system turnover.
• Experience with electronic validation systems (e.g., Kneat) is a plus.

Responsibilities

• Execute commissioning, qualification, and verification (CQV) activities for downstream manufacturing systems and utilities.
• Support installation verification and field execution through review of drawings, P&IDs, and system documentation.
• Perform hands-on testing, troubleshooting, and field walkdowns for large-scale equipment including pumps, filters, valves, and piping systems.
• Collaborate with engineering, operations, and quality teams to resolve issues and maintain project timelines across multiple manufacturing suites.
• Assist in development and completion of electronic documentation and turnover packages, ensuring compliance with internal and regulatory standards.

Skills

CQV experience

Validation

Engineering background

Equipment troubleshooting

Tools

Kneat

Job description

Piper Companies is seeking a Downstream CQV Engineer to join a growing organization within the life sciences and biopharmaceutical manufacturing industry. This is an onsite, 6-month contract role with potential extensions, based in Holly Springs, NC. The Downstream CQV Engineer will support large-scale manufacturing operations with a primary focus on downstream systems, utilities, and commissioning and qualification activities across a multi-building production environment.

Responsibilities of the Downstream CQV Engineer:

• Execute commissioning, qualification, and verification (CQV) activities for downstream manufacturing systems and utilities
• Support installation verification and field execution through the review of drawings, P&IDs, and system documentation
• Perform hands‑on testing, troubleshooting, and field walkdowns for large-scale equipment including pumps, filters, valves, and piping systems
• Collaborate with engineering, operations, and quality teams to resolve issues and maintain project timelines across multiple manufacturing suites
• Assist in the development and completion of electronic documentation and turnover packages, ensuring compliance with internal and regulatory standards

Qualifications for the Downstream CQV Engineer:

• 2–10 years of hands‑on experience in CQV, validation, or engineering within large-scale manufacturing environments
• Experience working with downstream processing equipment; ultrafiltration experience strongly preferred
• Mechanical or engineering‑focused background with the ability to inspect, troubleshoot, and work directly with equipment and instrumentation
• Familiarity with installation verification, utilities qualification, and system turnover processes
• Experience with electronic validation systems (e.g., Kneat) is a plus

Compensation for the Downstream CQV Engineer:

• Salary Range: $100,000 – $140,000/year (USD)
• Comprehensive Benefits: Medical, Dental, Vision, 401(k), and applicable sick leave

Keywords: CQV engineer, commissioning, qualification, validation, downstream processing, ultrafiltration, IV, P&IDs, utilities qualification, large scale manufacturing, biopharmaceuticals, GMP, mechanical engineering, process equipment, pumps, filters, valves, Kneat, system turnover, field execution, equipment qualification, biotech manufacturing, water systems, UF systems.

This position opened for applications on August 21st, 2026, and will remain open for at least 30 days from the posting date.