Data System Analyst
Sanofi
June 25, 2026
On-site
Framingham, MA
$85,500 - $123,500 USD yearly
IT
Main Responsibilities:
- Serve as site administrator for the Enterprise Content Management system and commonly used analytical laboratory equipment software applications.
- Program, maintain, and troubleshoot data storage, archival, and restore functions; resolve data management system issues with IS and external vendors.
- Collaborate with IS, Digital, and external vendors to develop, configure, and implement computer-based system applications.
- Provide local IT support for lab infrastructure and equipment software applications.
Digital Transformation & Automation:
- Support connected systems and automated data capture (electronic signatures, digital audit trails, automated notifications) in accordance with GxP.
- Implement systems for equipment lifecycle management, maintenance tracking, and resource management within the Sanofi laboratory workflow application.
- Partner with Automation, Digital, and IS teams to support automation initiatives.
Compliance & Validation:
- Prepare URS, impact assessments, lab instrument audit trails, deviations, change controls, and risk analyses for new/modified equipment/software.
- Author SOPs and training materials for data management and digital workflows.
- Support Computer System Validation (CSV) with Validation teams.
- Collaborate with Quality Assurance to uphold data integrity and ensure audit readiness.
- Share on-call duties for Environmental Monitoring System (EMS) for GMP equipment.
Cross-Functional Collaboration:
- Liaison between Operations, Validation, QA, Digital/IS, and external vendors.
- Facilitate training and drive adoption of new digital tools.
Modernization & Continuous Improvement:
- Evaluate emerging tools and industry best practices for analytical laboratory operations.
- Support change management for digital transformation initiatives.
Qualifications:
- Master’s degree in relevant fields (or related) + >2 years relevant experience, or Bachelor’s degree + ≥3 years relevant experience (Master’s students graduating summer/fall considered).
- Minimum 1 year experience in a cGMP environment.
- Strong organizational and communication skills; ability to manage cross-functional stakeholders.
- Ability to work independently and manage multiple priorities.
- Demonstrated experience with laboratory data management systems (ECM or equivalent).
Preferred Qualifications:
- Experience with Biovia automated laboratory workflows or equivalent platforms.
- Familiarity with CSV principles and FDA 21 CFR Part 11.
- Knowledge of GMP data integrity requirements.
- Serve as site administrator for the Enterprise Content Management system and commonly used analytical laboratory equipment software applications.
- Program, maintain, and troubleshoot data storage, archival, and restore functions; resolve data management system issues with IS and external vendors.
- Collaborate with IS, Digital, and external vendors to develop, configure, and implement computer-based system applications.
- Provide local IT support for lab infrastructure and equipment software applications.
Digital Transformation & Automation:
- Support connected systems and automated data capture (electronic signatures, digital audit trails, automated notifications) in accordance with GxP.
- Implement systems for equipment lifecycle management, maintenance tracking, and resource management within the Sanofi laboratory workflow application.
- Partner with Automation, Digital, and IS teams to support automation initiatives.
Compliance & Validation:
- Prepare URS, impact assessments, lab instrument audit trails, deviations, change controls, and risk analyses for new/modified equipment/software.
- Author SOPs and training materials for data management and digital workflows.
- Support Computer System Validation (CSV) with Validation teams.
- Collaborate with Quality Assurance to uphold data integrity and ensure audit readiness.
- Share on-call duties for Environmental Monitoring System (EMS) for GMP equipment.
Cross-Functional Collaboration:
- Liaison between Operations, Validation, QA, Digital/IS, and external vendors.
- Facilitate training and drive adoption of new digital tools.
Modernization & Continuous Improvement:
- Evaluate emerging tools and industry best practices for analytical laboratory operations.
- Support change management for digital transformation initiatives.
Qualifications:
- Master’s degree in relevant fields (or related) + >2 years relevant experience, or Bachelor’s degree + ≥3 years relevant experience (Master’s students graduating summer/fall considered).
- Minimum 1 year experience in a cGMP environment.
- Strong organizational and communication skills; ability to manage cross-functional stakeholders.
- Ability to work independently and manage multiple priorities.
- Demonstrated experience with laboratory data management systems (ECM or equivalent).
Preferred Qualifications:
- Experience with Biovia automated laboratory workflows or equivalent platforms.
- Familiarity with CSV principles and FDA 21 CFR Part 11.
- Knowledge of GMP data integrity requirements.