Remote Senior Validation Engineer – Lead GMP Validation

BioSpace; Hillsboro (OR); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Fully remote work options

Generous paid time off

Company-paid holidays

Career development opportunities

Job summary

Syner‑G in the biopharma space seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments. This role develops, executes, and manages validation lifecycle documentation while ensuring regulatory compliance.

The Sr. Validation Engineer will mentor junior staff, support complex projects, and provide guidance to teams, aligning validation with

Qualifications

• Strong verbal and written communication skills.
• Experience with FDA cGMP and risk-based validation.
• Ability to lead validation workstreams and mentor staff.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, and validated assets.
• Oversee internal and client tech transfer validation activities; author/review CVs, IQ/OQ/PQ, test methods, and reports.
• Prepare comprehensive summary reports for validation, verification, commissioning and requalification.

Skills

Verbal communication

Written communication

Organizational skills

Mentoring

Problem solving

Education

Bachelor’s degree in life science or engineering

Job description

Syner‑G in the biopharma space seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments. This role develops, executes, and manages validation lifecycle documentation while ensuring regulatory compliance.

The Sr. Validation Engineer will mentor junior staff, support complex projects, and provide guidance to teams, aligning validation with