Quality Assurance Validation Engineer - GMP Systems

Sanofi Group; Waltham (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Sanofi US seeks a Quality Assurance Validation Engineer for its mRNA Center of Excellence in Waltham, MA. The role supports Validation, Metrology and Automation, ensuring cGMP compliance and Data Integrity across equipment and systems.

You will prepare validation deliverables, participate in audits, and collaborate with cross-functional teams to uphold quality standards and project timelines. Minimum 3+ years in pharma validation and a technical degree are required; experience with GMP and

Qualifications

• Minimum 3+ years of experience within a Validation organization in pharma/biotech/medical devices.
• Experience with field activities and qualification processes.
• Knowledge of GMP, data integrity, and regulatory inspections.
• Ability to author and maintain validation documentation and SOPs.
• Strong problem solving and cross-functional collaboration skills.

Responsibilities

• Provide QA oversight for GMP validation activities and drive timely deliverables.
• Support end-to-end validation plans for facilities, utilities, systems, and equipment.
• Participate in internal audits and inspections, supporting documentation and investigations.
• Ensure compliance with US/EU/ICH GMP requirements and Data Integrity initiatives.
• Collaborate with cross-functional teams to uphold validation standards and continuous improvement.

Skills

Excellent communication

Team leadership

Interpersonal skills

Project coordination

Education

Bachelor's degree in mechanical engineering, chemical engineering, computer science, or related fields

Tools

NIST traceability

Validation protocols

Job description

Sanofi US seeks a Quality Assurance Validation Engineer for its mRNA Center of Excellence in Waltham, MA. The role supports Validation, Metrology and Automation, ensuring cGMP compliance and Data Integrity across equipment and systems.

You will prepare validation deliverables, participate in audits, and collaborate with cross-functional teams to uphold quality standards and project timelines. Minimum 3+ years in pharma validation and a technical degree are required; experience with GMP and