Senior Validation Engineer - GMP Systems & CSV Expert

BioSpace; Greenville (NC); On-site; USD 85,000 - 130,000; Full time

Job summary

Syner-G is seeking a Validation Engineer with 4–7 years in validated environments to support equipment, utilities, facilities, computerized systems, and MES/eBR platforms in GMP-regulated settings.

You will develop, execute, review, and maintain validation documentation, ensuring data integrity and regulatory alignment while collaborating with Manufacturing, Quality, Engineering, and IT/OT teams.

Qualifications

• Bachelor's degree in a technical field and GMP exposure.
• 4-7 years of validation experience in regulated life sciences.
• Experience with MES/eBR validation and CSV activities.
• Familiarity with GMP, 21 CFR Part 11, and data integrity requirements.
• Experience with MES platforms is preferred.

Responsibilities

• Generate and maintain validation lifecycle documentation (IQ/OQ/PQ, validation plans, reports).
• Support MES and eBR implementation, qualification, and lifecycle management.
• Review requirements, risk assessments, traceability matrices, and deviations.
• Ensure alignment with GMP and regulatory requirements during validation activities.
• Assist with CAPAs, change controls, and system releases.
• Collaborate with Manufacturing, Quality, Engineering, and IT/OT teams.

Skills

GMP knowledge

Data integrity

Documentation skills

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field

Tools

PAS-X

PharmaSuite

Syncade

Opcenter

Job description

Syner-G is seeking a Validation Engineer with 4–7 years in validated environments to support equipment, utilities, facilities, computerized systems, and MES/eBR platforms in GMP-regulated settings.

You will develop, execute, review, and maintain validation documentation, ensuring data integrity and regulatory alignment while collaborating with Manufacturing, Quality, Engineering, and IT/OT teams.