Downstream CQV Engineer - Onsite in NC, GMP Validation

United Pharma; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

United Pharma in North Carolina is seeking experienced Downstream CQV Engineers to support a large-scale biopharmaceutical manufacturing project. The role focuses on commissioning, qualification, and validation for downstream equipment and systems in a GMP-regulated environment.

Candidates will execute IQ/OQ protocols, develop CQV documentation, and contribute to construction-to-CQV turnover. On-site work required in North Carolina, with collaboration across Engineering, Construction,

Qualifications

• 2–4+ years of hands-on downstream CQV experience in pharma or biopharmaceutical manufacturing.
• Direct experience executing IQ/OQ and equipment qualification activities.
• Experience in a GMP-regulated manufacturing environment.
• Construction-to-CQV turnover experience is required.
• Hands-on MC/MCC and system energization activities experience.
• Strong documentation and field troubleshooting skills.

Responsibilities

• Execute CQV activities for downstream biopharmaceutical equipment and systems.
• Develop, review, and execute IQ/OQ protocols and qualification documents.
• Support equipment and system turnover from Construction to CQV.
• Participate in Mechanical Completion (MC/MCC) activities and system energization.
• Review docs to confirm readiness for CQV execution.
• Perform field qualification testing and document results per procedures.
• Identify and resolve CQV issues and discrepancies with cross-functional teams.
• Communicate status and progress to project leadership.

Skills

CQV experience

IQ/OQ

GMP environment

Construction-to-CQV

Field troubleshooting

Documentation

On-site work

Job description

United Pharma in North Carolina is seeking experienced Downstream CQV Engineers to support a large-scale biopharmaceutical manufacturing project. The role focuses on commissioning, qualification, and validation for downstream equipment and systems in a GMP-regulated environment.

Candidates will execute IQ/OQ protocols, develop CQV documentation, and contribute to construction-to-CQV turnover. On-site work required in North Carolina, with collaboration across Engineering, Construction,