CQV Downstream Engineer

About the role

Our client, a global pharmaceutical manufacturing organization is seeking an experienced CQV Downstream Engineer to support the delivery of their large-scale CAPEX project based in North Carolina. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States. Initial 8‑Month Contract.

Responsibilities

• Support Installation Verification (IV) activities within downstream manufacturing systems.
• Support startup and commissioning readiness activities.
• Execute CQV lifecycle deliverables including FAT, SAT, IOC, IOQ, and associated documentation.
• Participate in field walkdowns and equipment inspections.
• Support turnover package review and acceptance activities.
• Coordinate with Operations, Automation, Construction, and CQV teams.

Requirements

• Extensive experience in biotech, biologics, pharmaceutical manufacturing, CQV, commissioning, validation, process engineering, or operations engineering.
• Exposure to downstream manufacturing systems.
• Exposure to installation verification (IV) activities.
• Experience supporting startup, commissioning, or qualification efforts.