Downstream CQV Engineer

United Pharma; North Carolina; On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma seeks a Downstream CQV Engineer to support commissioning, qualification, and validation activities at a newly built biologics facility. This role focuses on downstream processing systems, field execution, equipment verification, and operational readiness throughout the CQV lifecycle.

You will execute CQV activities across IV, OV, and PQ phases, perform field verifications, read P&IDs, and collaborate with Engineering, Validation, Manufacturing, and Quality teams to ensure smooth

Qualifications

• 5+ years in CQV, validation, or process engineering in GMP environments.
• Experience in at least two CQV phases: IV, OV, PQ.
• Hands-on field execution and equipment verification experience.
• Ability to read P&IDs and perform system walkdowns.
• Experience with downstream biologics manufacturing equipment is preferred.
• Biologics/pharma startup experience preferred.

Responsibilities

• Execute CQV activities across IV, OV, and PQ phases.
• Perform field verification, system checks, equipment startup, and walkthroughs.
• Conduct P&ID reviews and line walkdowns.
• Support downstream systems including buffer preparation, chromatography, ultrafiltration, and bulk fill.
• Troubleshoot mechanical and process-related issues during execution.
• Support protocol execution, documentation, and validation readiness.
• Collaborate with Engineering, Validation, Manufacturing, and Quality teams.
• Support startup and commissioning activities within a greenfield facility.

Skills

CQV / validation experience

Field execution

P&ID reading

Troubleshooting

Cross-functional collaboration

Downstream biologics knowledge

Greenfield startup experience

Tools

DeltaV

HMI

Kneat

Job description

We are seeking a Downstream CQV Engineer to support commissioning, qualification, and validation activities at a newly built biologics manufacturing facility. This role will focus on downstream processing systems, field execution, equipment verification, and operational readiness throughout the CQV lifecycle.

Key Responsibilities:

• Execute CQV activities across IV, OV, and PQ phases
• Perform field verification, system checks, equipment startup, and walkthroughs
• Conduct P&ID reviews and line walkdowns
• Support downstream systems including buffer preparation, chromatography, ultrafiltration, and bulk fill
• Troubleshoot mechanical and process-related issues during execution
• Support protocol execution, documentation, and validation readiness
• Collaborate with Engineering, Validation, Manufacturing, and Quality teams
• Support startup and commissioning activities within a greenfield facility

Skills & Qualifications:

• 5+ years of CQV, validation, or process engineering experience in GMP environments
• Experience with at least two CQV phases: IV, OV, PQ
• Strong hands-on field execution and equipment verification experience
• Ability to read and interpret P&IDs and perform system walkdowns
• Experience with downstream biologics manufacturing equipment
• Strong troubleshooting and problem-solving skills
• Experience with DeltaV, HMI, Kneat, or validation documentation is a plus
• Biologics, pharma, greenfield/startup experience preferred