Senior Validation Engineer - Remote GMP/CSV Expert

BioSpace; San Diego (CA); On-site; USD 114,000 - 137,000; Full time

Benefits offered by this job

Fully remote work options

Office in San Diego

Job summary

Syner-G is seeking a Sr. Validation Engineer in San Diego to lead validation activities across equipment, utilities, facilities, and computerized systems in GMP‑regulated environments.

You will develop, execute, and manage validation lifecycle documentation, ensuring compliance with regulatory expectations and internal quality standards, while guiding junior engineers. This role requires 7–11 years in biotech/pharma, strong knowledge of FDA cGMP, and hands‑on experience with IQ/OQ/PQ, CSV, and

Qualifications

• Strong verbal and written communication skills are required.
• Experience leading validation workstreams and coordinating multi‑discipline teams.
• Knowledge of FDA cGMP and risk‑based validation principles.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ).
• Oversee internal and client tech transfer validation activities and documentation.
• Mentor junior validation staff and collaborate cross‑functionally to meet project timelines.

Skills

Verbal communication

Written communication

Leadership

Documentation

Problem solving

Education

Bachelor’s degree in life science/engineering

Tools

FAT/SAT/IOQ/PQ protocols

IQ/OQ/PQ documents

Change control systems

Job description

Syner-G is seeking a Sr. Validation Engineer in San Diego to lead validation activities across equipment, utilities, facilities, and computerized systems in GMP‑regulated environments.

You will develop, execute, and manage validation lifecycle documentation, ensuring compliance with regulatory expectations and internal quality standards, while guiding junior engineers. This role requires 7–11 years in biotech/pharma, strong knowledge of FDA cGMP, and hands‑on experience with IQ/OQ/PQ, CSV, and