Senior Validation Engineer — Remote, GMP/CSV Leader

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

Job summary

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

You will develop and manage validation lifecycle documentation, provide guidance to junior staff, and ensure regulatory alignment across projects. Qualified candidates have 7–11 years in biotech/pharma, strong FDA cGMP knowledge, and expertise in CSV, IQ/OQ/PQ, and risk-based validation principles.

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of experience in biotech, pharma, or medical device industries.
• Strong knowledge of FDA cGMP, FMEA, and risk-based validation principles.
• Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment and GMP-regulated assets.
• Oversee validation activities for tech transfer projects including IQ/OQ/PQ and CSV reports.
• Write, review, and revise qualification documents, SOPs, validation master plans, and design specifications.
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Develop procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Lead P&ID walkdowns to verify installation and system readiness; perform thermal mapping of temperature-controlled environments.

Skills

Leadership

Communication

Documentation

Organizational skills

Mentorship

Problem-solving

Education

Bachelor's degree in life science/engineering

Job description

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

You will develop and manage validation lifecycle documentation, provide guidance to junior staff, and ensure regulatory alignment across projects. Qualified candidates have 7–11 years in biotech/pharma, strong FDA cGMP knowledge, and expertise in CSV, IQ/OQ/PQ, and risk-based validation principles.