Senior Validation Engineer - MES/CSV Leader (Remote)

Synerg; Greenville (NC); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Fully remote options

Flexible paid time off

Office locations in strategic markets

Job summary

Syner-G is seeking a Sr. Validation Engineer to lead validation across equipment, utilities, facilities, and MES/eBR in GMP environments. You will develop and manage validation lifecycle documentation, ensuring regulatory alignment and data integrity while partnering with Manufacturing, Quality, and IT teams.

The role requires 7–11 years in biotech/pharma, strong CSV expertise, and hands-on MES/eBR experience, with mentorship responsibilities and cross-functional collaboration.

Qualifications

• Strong knowledge of FDA cGMP requirements and data integrity principles.
• Experience generating and reviewing validation documentation and reports.
• Expertise with MES/eBR validation and lifecycle management.

Responsibilities

• Lead validation lifecycle activities for equipment, utilities, and MES/eBR.
• Write and review validation master plans, protocols, and reports.
• Ensure compliance with 21 CFR Part 11 and data integrity standards.
• Mentor junior staff and collaborate across functions.

Skills

FDA cGMP knowledge

CSV / validation

Validation lifecycle

MES/eBR validation

IQ/OQ/PQ docs

Technical writing

Education

Bachelor's degree in Engineering or Life Sciences

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 in GMP environments. You will develop and manage validation lifecycle documentation, ensuring regulatory alignment and data integrity while partnering with Manufacturing, Quality, and IT teams.

The role requires 7–11 years in biotech/pharma, strong CSV expertise, and hands-on MES/eBR experience, with mentorship responsibilities and cross-functional collaboration.