Senior Validation Engineer — GMP/CSV & MES Expert

Syner-G BioPharma Group; Greenville, Northern (NC, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Syner-G BioPharma Group in the United States seeks a Senior Validation Engineer (QAV) with 4‑15 years of experience to support validation across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR in GMP environments.

You will develop, execute, review, and maintain validation lifecycle documentation, ensuring regulatory compliance, data integrity, and alignment with GMP requirements while collaborating with cross-functional teams for system releases and

Qualifications

• Experience providing QA/validation oversight for MES/eBR implementation.
• Ability to review requirements, risk assessments, and validation reports.
• Familiar with GMP, data integrity, and CSV requirements.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Generate and review validation plans, protocols, and reports for equipment and systems.
• Support MES/eBR validation and qualification activities.
• Ensure 21 CFR Part 11 and data integrity compliance.
• Collaborate with Manufacturing, Validation, IT/OT, and Quality teams.

Skills

Validation lifecycle

Quality systems (GMP/21 CFR Part 11)

Technical writing

Cross-functional collaboration

Education

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

Tools

PAS-X

PharmaSuite

Syncade

Opcenter

Job description

Syner-G BioPharma Group in the United States seeks a Senior Validation Engineer (QAV) with 4‑15 years of experience to support validation across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR in GMP environments.

You will develop, execute, review, and maintain validation lifecycle documentation, ensuring regulatory compliance, data integrity, and alignment with GMP requirements while collaborating with cross-functional teams for system releases and