Senior Validation Engineer - GMP/CSV Expert (Remote)

Syner-G; Raleigh (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

Syner-G is seeking a Sr. Validation Engineer to lead validation across equipment, utilities, facilities, and computerized systems in GMP-regulated environments. You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory compliance and quality standards.

The role requires 7–11 years in biotech/pharma, strong knowledge of FDA cGMP, and experience with IQ/OQ/PQ and CSV reporting. This position offers growth and impact within a supportive team.

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of experience in biotech/pharma or medical devices.
• Strong knowledge of FDA cGMP and risk-based validation principles.
• Experience generating and reviewing IQ, OQ, PQ and CSV reports.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for assets and processes.
• Oversee validation activities for tech transfer projects and related reports.
• Write, review, and revise qualification documents and SOPs.
• Develop summary reports for validation, commissioning, and requalification.
• Mentor junior validation staff and collaborate cross-functionally.

Skills

Validation leadership

Regulatory compliance

Written communication

Project management

Education

Bachelor's degree in life science/engineering

Tools

IQ/OQ/PQ protocols

FAT/SAT documentation

CSV (computerized systems validation)

Job description

Syner-G is seeking a Sr. Validation Engineer to lead validation across equipment, utilities, facilities, and computerized systems in GMP-regulated environments. You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory compliance and quality standards.

The role requires 7–11 years in biotech/pharma, strong knowledge of FDA cGMP, and experience with IQ/OQ/PQ and CSV reporting. This position offers growth and impact within a supportive team.