QA Validation Engineer: GMP & Data Integrity

BioSpace; Waltham (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Sanofi is seeking a Quality Assurance Validation Engineer in Waltham, MA to support GMP validation activities across facilities and systems. This role partners with Validation, Metrology, and Automation teams, ensuring compliance with cGMP and regulatory expectations, and leading SOP development and audit support.

The ideal candidate has 3+ years in validation within pharma/biotech, strong data integrity experience, and excellent communication skills to collaborate with diverse teams.

Qualifications

• Bachelor's degree in mechanical engineering, chemical engineering, computer science, or related biotech/pharma field.
• Minimum 3+ years of experience in a Validation organization within the pharmaceutical, biologics, or medical device industries.
• Experience with validation protocols, commissioning/qualification activities, and related supporting documentation.
• Experience in data integrity and compliance with US/EU/ICH GMP requirements.

Responsibilities

• Provide QA oversight for GMP validation activities and apply risk-based methods to drive timely, compliant deliverables.
• Support end-to-end Validation lifecycle for facilities, utilities, systems and equipment across sites.
• Author and maintain SOPs for GMP-related validation activities and ensure alignment with internal/global standards.
• Support internal audits and inspections with documentation, investigations, and remediation activities as needed.
• Partner with Metrology and Automation teams to ensure Data Integrity and cGMP compliance across equipment.

Skills

Validation experience

GMP compliance

Data Integrity

Regulatory knowledge

Communication skills

Education

Bachelor's degree in mechanical engineering

Bachelor's degree in chemical engineering

Bachelor's degree in computer science

Job description

Sanofi is seeking a Quality Assurance Validation Engineer in Waltham, MA to support GMP validation activities across facilities and systems. This role partners with Validation, Metrology, and Automation teams, ensuring compliance with cGMP and regulatory expectations, and leading SOP development and audit support.

The ideal candidate has 3+ years in validation within pharma/biotech, strong data integrity experience, and excellent communication skills to collaborate with diverse teams.