CQV Equipment Validation Engineer (GMP)

Energy Jobline ZR; Raleigh (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Dental insurance

Vision insurance

401K plan with employer contributions

Job summary

Alliance Biotech Solutions has multiple openings for Validation Engineers to support CQV activities for GMP equipment in a CDMO setting. You will execute IQ/OQ/PQ protocols, drive qualification of new process equipment, and ensure rigorous documentation aligned with FDA and global standards.

Collaborate with Manufacturing, Quality, Engineering and Automation to support system integration and CSV/data integrity activities.

Qualifications

• Execute IQ/OQ/PQ protocol development and reporting in GMP settings.
• Support validation for single-use systems and lab instruments.
• CSV and data integrity concepts are a plus; strong GMP knowledge.

Responsibilities

• Execute and support equipment qualification activities including IQ/OQ/PQ protocol development, execution, and report.
• Support validation efforts for single-use systems including SUMs, process pumps, and filtration systems.
• Participate in qualification of lab instruments such as Vi-Cell BLU with CSV support.
• Perform on-the-floor validation execution including walkdowns and functional testing.
• Collaborate with cross-functional teams to align validation with project timelines.

Skills

Technical writing

Analytical thinking

Cross-functional collaboration

Problem solving

Independent work

Prioritization

Communication skills

Tools

KNEAT

TrackWise

Veeva

Job description

Alliance Biotech Solutions has multiple openings for Validation Engineers to support CQV activities for GMP equipment in a CDMO setting. You will execute IQ/OQ/PQ protocols, drive qualification of new process equipment, and ensure rigorous documentation aligned with FDA and global standards.

Collaborate with Manufacturing, Quality, Engineering and Automation to support system integration and CSV/data integrity activities.