Senior Validation Engineer - Lead GMP/CSV (Remote)

Syner-G; Raleigh (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Remote work options

Office locations in USA

Job summary

Syner-G in Raleigh, NC is seeking a Sr. Validation Engineer with 7-11 years of experience to lead validation across equipment, utilities, facilities, and computerized systems in GMP environments. You will develop, execute and manage validation lifecycle documents while ensuring regulatory compliance.

You will mentor junior staff, collaborate cross-functionally, and drive validation programs, risk assessments, IQ/OQ/PQ, and commissioning tests to support continuous quality and site performance.

Qualifications

• 7-11 years in biotech/pharma/medical device
• Strong knowledge of FDA cGMP, FMEA and risk-based validation principles
• Experience generating validated protocols and CSV/IQ/OQ/PQ reports

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities and processes.
• Oversee internal and client tech transfer validation activities and documentation.
• Write and review qualification/verification documents (SOPs, master plans, URS/FRS, design specs, FAT).
• Prepare comprehensive validation summary reports and support regulatory responses.

Skills

FDA cGMP

CSV validation

Risk-based validation

Team mentorship

Leadership

Education

Bachelor’s degree in life science or engineering

Job description

Syner-G in Raleigh, NC is seeking a Sr. Validation Engineer with 7-11 years of experience to lead validation across equipment, utilities, facilities, and computerized systems in GMP environments. You will develop, execute and manage validation lifecycle documents while ensuring regulatory compliance.

You will mentor junior staff, collaborate cross-functionally, and drive validation programs, risk assessments, IQ/OQ/PQ, and commissioning tests to support continuous quality and site performance.