Senior Validation Engineer — GMP, MES/CSV Leader

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

Benefits offered by this job

Fully remote work options

Office locations: Greater Boston, San-

Office locations: Boulder, CO; India

Job summary

Syner-G is seeking a Sr. Validation Engineer to lead validation across equipment, utilities, facilities, and MES/eBR platforms in GMP environments. You will develop, execute, and review lifecycle documentation while ensuring regulatory alignment and data integrity.

You will partner with Manufacturing, Quality, Validation, Automation, and IT/OT teams to drive successful qualification, system deployment, and ongoing compliance. A strong background in FDA cGMP and MES/eBR validation is essential.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
• 7–11 years in biotech/pharma/medical device industry.
• Strong knowledge of FDA cGMP requirements, risk-based validation methodologies, and quality system requirements.
• Experience with MES and eBR validation, implementation, qualification, or lifecycle management in GMP environments.
• Experience generating and reviewing validation documentation (IQ/OQ/PQ, CSV, etc.).
• Excellent technical writing and cross-functional collaboration skills.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) for equipment, utilities, facilities, cleaning processes, and GMP systems.
• Provide QA/Validation oversight for MES and eBR implementations and lifecycle activities.
• Review requirements, risk assessments, traceability matrices, validation plans, protocols, deviations and reports.
• Ensure compliance with 21 CFR Part 11, GMP, data integrity, and CSV best practices.
• Support audits, CAPAs, change controls, and system releases for MES/eBR and other GMP systems.
• Mentor junior validation staff and coordinate cross-functional teams.

Skills

Validation expertise

GMP knowledge

CSV (computerized systems validation)

FDA cGMP

MES/eBR validation

Documentation writing

Cross-functional collaboration

Education

Bachelors in Engineering / Life Sciences / CS

Tools

PAS-X

PharmaSuite

Syncade

Opcenter

Job description

Syner-G is seeking a Sr. Validation Engineer to lead validation across equipment, utilities, facilities, and MES/eBR platforms in GMP environments. You will develop, execute, and review lifecycle documentation while ensuring regulatory alignment and data integrity.

You will partner with Manufacturing, Quality, Validation, Automation, and IT/OT teams to drive successful qualification, system deployment, and ongoing compliance. A strong background in FDA cGMP and MES/eBR validation is essential.