Validation Engineer: GMP, MES & CSV Specialist

Syner G; United States; Remote; USD 95,000 - 130,000; Full time

Benefits offered by this job

Fully remote work options

Flexible paid time off

Job summary

Syner-G is seeking a Validation Engineer with 4–7 years of experience to support validation across equipment, utilities, facilities, computerized systems, and MES/eBR platforms in GMP environments. You will develop, execute, review, and maintain validation docs ensuring data integrity and regulatory alignment.

The role involves MES/eBR implementation support, cross-functional collaboration, and system release activities to ensure quality and compliance in manufacturing processes.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or related.
• 4-7 years of validation experience in regulated life sciences.
• Experience with IQ/OQ/PQ protocols and validation reports.

Responsibilities

• Create and execute validation lifecycle docs (IQ/OQ/PQ, FAT/SAT).
• Support MES/eBR validation and lifecycle management.
• Review risk assessments, traceability, deviations, and validation reports for compliance.
• Assist with deviations, CAPAs, change controls, and system releases.
• Prepare validation summary reports and support transfer activities.

Skills

GMP knowledge

CSV validation

MES/eBR

Regulatory compliance

Education

Bachelor’s degree in Engineering/Life Sciences

Tools

PAS-X

PharmaSuite

Syncade

Opcenter

Job description

Syner-G is seeking a Validation Engineer with 4–7 years of experience to support validation across equipment, utilities, facilities, computerized systems, and MES/eBR platforms in GMP environments. You will develop, execute, review, and maintain validation docs ensuring data integrity and regulatory alignment.

The role involves MES/eBR implementation support, cross-functional collaboration, and system release activities to ensure quality and compliance in manufacturing processes.