Senior Validation Engineer: GMP/CSV Lead

Doist; Hillsboro (OR); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Fully remote work options

Competitive benefits

Job summary

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, and CSV in GMP environments. You will develop, execute, and manage validation lifecycle docs, supporting regulatory expectations and senior project goals.

You will mentor junior staff, coordinate with cross-functional teams, and drive successful tech transfers and requalifications across validated assets, ensuring quality and compliance.

Qualifications

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

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities.
• Oversee validation activities for internal and client tech transfer projects; authoring and reviewing IQ/OQ/PQ & CSV reports.
• Mentor junior validation staff and collaborate cross-functionally to align with project timelines.

Skills

Communication

Documentation

Leadership

Mentorship

Independent work

Education

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

Tools

CSV/Quality docs

Job description

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, and CSV in GMP environments. You will develop, execute, and manage validation lifecycle docs, supporting regulatory expectations and senior project goals.

You will mentor junior staff, coordinate with cross-functional teams, and drive successful tech transfers and requalifications across validated assets, ensuring quality and compliance.