Onsite Downstream CQV Engineer - Contract (Biopharma)

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

Benefits offered by this job

Medical

Dental

Vision

401(k)

Sick leave

Job summary

Piper Companies is seeking a Downstream CQV Engineer to join its biopharmaceutical manufacturing team onsite in Holly Springs, NC. This 6-month contract role with potential extensions focuses on commissioning, qualification, and validation of downstream systems and utilities across a multi-building facility.

The ideal candidate has 2–10 years of CQV/validation experience, hands-on equipment knowledge (pumps, filters, valves), and familiarity with Kneat or electronic validation systems, to

Qualifications

• 2-10 years of hands-on CQV, validation, or engineering experience in large-scale manufacturing environments.
• Experience with downstream processing equipment; ultrafiltration experience strongly preferred.
• Mechanical or engineering background with 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.

Responsibilities

• 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

Skills

CQV experience

Validation

Engineering

Downstream processing

Pumps & valves

Documentation

Kneat

Tools

Kneat

Job description

Piper Companies is seeking a Downstream CQV Engineer to join its biopharmaceutical manufacturing team onsite in Holly Springs, NC. This 6-month contract role with potential extensions focuses on commissioning, qualification, and validation of downstream systems and utilities across a multi-building facility.

The ideal candidate has 2–10 years of CQV/validation experience, hands-on equipment knowledge (pumps, filters, valves), and familiarity with Kneat or electronic validation systems, to