Senior Validation Engineer - GMP/MES Specialist

Syner G; Greenville (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Remote work options

Flexible paid time off

Office locations: Boston, San Diego, B

Career development

Job summary

Syner-G seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, MES/eBR platforms within GMP environments.

You will develop, execute, review, and manage validation lifecycle documentation ensuring regulatory expectations and data integrity. The role partners with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful deployment, qualification, and ongoing compliance.

Qualifications

• 7–11 years of experience in biotech/pharma/medical device.
• Strong knowledge of FDA cGMPs, data integrity, CSV.
• Experience with MES/eBR validation and lifecycle management.
• Experience reviewing protocols, reports, risk assessments, and change controls.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) for equipment, utilities, facilities, and computerized systems.
• Provide QA/Validation oversight for MES/eBR implementations.
• Review requirements, risk assessments, traceability, validation plans, and reports.
• Ensure compliance with 21 CFR Part 11, GMP, and data integrity requirements.
• Collaborate with Manufacturing, Quality, Validation, Automation, and IT/OT teams.

Skills

Regulatory compliance

Validation leadership

Documentation writing

Cross-functional collaboration

Quality systems

Education

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

Tools

MES platforms (PAS-X, PharmaSuite, Syncade, Opcenter)

Job description

Syner-G seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, MES/eBR platforms within GMP environments.

You will develop, execute, review, and manage validation lifecycle documentation ensuring regulatory expectations and data integrity. The role partners with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful deployment, qualification, and ongoing compliance.