Downstream CQV Engineer — Onsite GMP Validation Expert

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

Job summary

Piper Companies is seeking a Downstream CQV Engineer to join its life sciences manufacturing team in Holly Springs, NC. This onsite 6-month contract role focuses on commissioning and qualification of downstream systems, utilities, and large-scale equipment across multiple suites.

Responsibilities include CQV execution, document turnover, and cross-functional coordination with engineering, operations and quality to maintain project timelines and regulatory compliance.

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, troubleshoot, and work with equipment.
• Familiarity with installation verification, utilities qualification, and system turnover processes.
• Experience with electronic validation systems (e.g., Kneat) is a plus.

Responsibilities

• Execute CQV activities for downstream manufacturing systems and utilities.
• Review drawings, P&IDs, and system documentation to support verification.
• Perform hands-on testing, troubleshooting, and field walkdowns for large-scale equipment.
• Collaborate with engineering, operations, and quality teams to resolve issues and meet timelines.
• Assist in development and turnover documentation ensuring regulatory compliance.

Skills

CQV experience

Hands-on testing

Troubleshooting

Mechanical engineering

System turnover

Education

Mechanical engineering degree

Bachelor's in engineering

Tools

Kneat

P&IDs

Job description

Piper Companies is seeking a Downstream CQV Engineer to join its life sciences manufacturing team in Holly Springs, NC. This onsite 6-month contract role focuses on commissioning and qualification of downstream systems, utilities, and large-scale equipment across multiple suites.

Responsibilities include CQV execution, document turnover, and cross-functional coordination with engineering, operations and quality to maintain project timelines and regulatory compliance.