Senior Validation Engineer - Lead GMP/CSV Validation Remote

Synerg; Hillsboro (OR); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Flexible paid time off

Company-paid holidays

Flexible working hours

Fully remote work options

Job summary

Syner-G in Hillsboro, OR is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across GMP-regulated assets, including equipment, utilities, facilities, and computerized systems.

You'll develop, execute and manage validation lifecycle documentation, ensure regulatory compliance, and mentor junior staff while collaborating across functions to meet project timelines.

Qualifications

• Bachelor’s degree in life science, engineering, or related technical field.
• 7–11 years of experience in biotech, pharmaceutical, or medical device industry.
• Experience writing and reviewing IQ, OQ, PQ, and CSV reports.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP-regulated assets.
• Oversee validation activities for internal and client tech transfer projects; authoring and closing validation docs.
• Mentor junior validation staff and collaborate cross-functionally to meet timelines.

Skills

FDA cGMP knowledge

CSV validation

Project leadership

Mentoring

Communication skills

Education

Bachelor’s degree in life science, engineering, or related technical field

Job description

Syner-G in Hillsboro, OR is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across GMP-regulated assets, including equipment, utilities, facilities, and computerized systems.

You'll develop, execute and manage validation lifecycle documentation, ensure regulatory compliance, and mentor junior staff while collaborating across functions to meet project timelines.