Senior Validation Engineer — Remote in Validation

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

Job summary

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes in GMP environments.

You will develop, execute, and manage validation lifecycle documentation, ensure regulatory compliance, and mentor junior team members. You will lead P&ID walkdowns, thermal mapping, and preparation of comprehensive validation reports, while supporting audits and change controls within a

Qualifications

• 7–11 years of experience in biotech/pharma/medical device industries.
• Strong knowledge of FDA cGMP requirements, risk-based validation.
• Experience generating and reviewing IQ, OQ, PQ, CSV reports.
• Audits/regulatory inspections support experience.
• Ability to mentor junior staff and lead validation workstreams.

Responsibilities

• Lead creation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, and systems.
• Oversee validation activities for internal and client tech transfer projects and related reports.
• Write, review, and revise qualification/verification documents and SOPs.
• Prepare summary reports for validation, verification, commissioning, and requalification.
• Develop procedures, investigations, and change controls across Maintenance, Engineering, and Quality functions.
• Lead P&ID walkdowns to verify installation and readiness.
• Perform thermal mapping of temperature-controlled environments and SIP processes.
• Support regulatory observations and site issues related to validation.
• Mentor junior engineers and collaborate across functions to align with timelines.

Skills

Regulatory compliance

Validation lifecycle

Documentation proficiency

Mentorship

Cross-functional collaboration

Education

Bachelor's degree in life science/engineering

Tools

CSV / Computerized Systems Validation

FAT/SAT/IOQ/PQ documentation

Job description

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes in GMP environments.

You will develop, execute, and manage validation lifecycle documentation, ensure regulatory compliance, and mentor junior team members. You will lead P&ID walkdowns, thermal mapping, and preparation of comprehensive validation reports, while supporting audits and change controls within a