Senior Validation Engineer: GMP Systems Lead

BioSpace; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Syner-G seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments.

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory compliance and quality standards. The role includes mentoring junior staff, supporting complex projects, and collaborating cross-functionally to align validation activities with project

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of biotech, pharmaceutical, or medical device experience.
• Strong knowledge of FDA cGMP, FMEA, and risk-based validation principles.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ).
• Oversee validation activities for internal and client tech transfer projects, including IQ/OQ/PQ and validation reports.
• Write, review, and revise qualification and verification documents (SOPs, validation master plans, URS/ FRS, design specs, FAT).
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification.

Skills

Strong communication

Documentation

Leadership

Independent worker

Education

Bachelor’s degree in life science/engineering

Job description

Syner-G seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments.

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory compliance and quality standards. The role includes mentoring junior staff, supporting complex projects, and collaborating cross-functionally to align validation activities with project