CQV Project Engineer - Biopharma | Remote Options

BioSpace; Gaithersburg (MD); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible paid time off

Company-paid holidays

Flexible working hours

Fully remote work options (for many,if

Remote work options

Job summary

Syner-G seeks experienced Project Engineers to support commissioning and qualification in GMP-regulated biopharma manufacturing. Focus is on IQ development for bioreactors, hold tanks, and related systems, with CQV expertise and regulatory compliance understanding.

Travel to client sites up to 100% may be required. Candidates should have hands-on CQV experience, strong documentation skills, and ability to work with cross-functional teams to ensure system turnover and qualification readiness.

Qualifications

• Strong CQV knowledge and equipment qualification principles.
• Experience developing and executing IQ protocols for process equipment.
• Familiarity with GMP/GDP and regulatory compliance.

Responsibilities

• Develop, review, and execute IQ protocols for bioreactors and process equipment.
• Verify installation against P&IDs and vendor documentation.
• Perform field walkdowns, inspections, and verification activities.
• Identify and resolve qualification discrepancies and deviations.
• Collaborate with Engineering, Manufacturing, QA, Validation, and vendors to support turnover.
• Support commissioning and qualification activities per GMP procedures.
• Maintain complete qualification documentation for inspections.

Skills

CQV methodologies

IQ protocols

GMP knowledge

P&IDs interpretation

Documentation

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

Kneat

Job description

Syner-G seeks experienced Project Engineers to support commissioning and qualification in GMP-regulated biopharma manufacturing. Focus is on IQ development for bioreactors, hold tanks, and related systems, with CQV expertise and regulatory compliance understanding.

Travel to client sites up to 100% may be required. Candidates should have hands-on CQV experience, strong documentation skills, and ability to work with cross-functional teams to ensure system turnover and qualification readiness.