QA Validation Engineer – mRNA GMP Compliance

Sanofi Group; United States; On-site; USD 78,000 - 113,000; Full time

Benefits offered by this job

Parental leave

Health benefits

Job summary

Sanofi seeks a QAV Engineer to support Validation, Metrology and Automation across its mRNA Center of Excellence. You will report to the Deputy Director, Quality Assurance Validation, and help drive QA validation activities for GMP-compliant facilities and computerized systems.

The role requires 3+ years in pharmaceutical validation, strong collaboration across technical teams, and a commitment to data integrity and regulatory standards across US and global sites.

Qualifications

• Requires a Bachelor’s degree in mechanical engineering, chemical engineering, computer science, or related fields.
• Minimum 3+ years in a Validation organization within pharma/biologics/medical devices.
• Experience with facility startups, commissioning/qualification, and associated documentation.
• Experience improving Validation operations in response to audits/regulatory inspections.
• Experience executing field activities for validation protocols and data analysis.

Responsibilities

• Support Validation, Automation, Metrology and Quality Control teams to ensure end-to-end validation deliverables across facilities and equipment.
• Provide QA oversight for GMP validation activities and apply risk-based methods.
• Develop project plans, validation deliverables, and field activity support for QA Validation.
• Ensure compliance with internal/global standards and responsibilities for Data Integrity initiatives.
• Author and maintain SOPs for GMP equipment and computer system validation.
• Support new and existing facility validation strategies and related laboratory validations.
• Provide QA assessment of GMP validated system procedures, deviations, CAPAs and change controls as needed.
• Assist during internal audits, inspections, investigations and remediation activities.
• Act as QA SME for Metrology and Automation, ensuring Data Integrity and cGMP compliance.

Skills

QA Validation

GMP Compliance

Risk-Based Validation

Cross-Functional Collaboration

Data Integrity

Education

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

Tools

Validation software

NIST traceability

Job description

Sanofi seeks a QAV Engineer to support Validation, Metrology and Automation across its mRNA Center of Excellence. You will report to the Deputy Director, Quality Assurance Validation, and help drive QA validation activities for GMP-compliant facilities and computerized systems.

The role requires 3+ years in pharmaceutical validation, strong collaboration across technical teams, and a commitment to data integrity and regulatory standards across US and global sites.