Data System Analyst
Sanofi
June 25, 2026
On-site
Waltham, 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 for development, configuration, and implementation of 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) per GxP requirements.
- Lead equipment lifecycle management, maintenance tracking, and resource management system implementations within the lab workflow application.
- Support automation initiatives with Automation, Digital, and IS teams.
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.
- Partner with Quality Assurance to uphold data integrity and audit readiness.
- Participate in on-call duties for EMS for GMP equipment.
About You (Qualifications)
- Master’s in relevant field with >2 years’ experience, or Bachelor’s with ≥3 years’ experience (Master’s students graduating summer/fall considered).
- Minimum 1 year experience in a cGMP environment.
- Strong organization/communication; manage cross-functional stakeholders; work independently; manage multiple priorities.
- Demonstrated laboratory data management system experience (ECM or equivalent).
Preferred Qualifications
- Experience with Biovia automated laboratory workflows or equivalent platforms.
- Familiarity with CSV 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 for development, configuration, and implementation of 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) per GxP requirements.
- Lead equipment lifecycle management, maintenance tracking, and resource management system implementations within the lab workflow application.
- Support automation initiatives with Automation, Digital, and IS teams.
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.
- Partner with Quality Assurance to uphold data integrity and audit readiness.
- Participate in on-call duties for EMS for GMP equipment.
About You (Qualifications)
- Master’s in relevant field with >2 years’ experience, or Bachelor’s with ≥3 years’ experience (Master’s students graduating summer/fall considered).
- Minimum 1 year experience in a cGMP environment.
- Strong organization/communication; manage cross-functional stakeholders; work independently; manage multiple priorities.
- Demonstrated laboratory data management system experience (ECM or equivalent).
Preferred Qualifications
- Experience with Biovia automated laboratory workflows or equivalent platforms.
- Familiarity with CSV and FDA 21 CFR Part 11.
- Knowledge of GMP data integrity requirements.