Downstream CQV Engineer — Onsite Biotech GMP Validation

Zachary Piper Solutions

Holly Springs (MS)

On-site

USD 100,000 - 140,000

Full time

4 days ago

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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.