Job Title: Data System Analyst
About the jobThis position resides within the Operations group, which is part of the Global CMC Development organization and is responsible for supporting equipment management and qualification to ensure GMP compliance. In addition, the group plays a key role in enabling the digital transformation initiatives within the Bioanalytics teams at Sanofi in Framingham and Waltham, MA.
The ideal candidate has a strong technical background in computer systems, knowledge of commonly used equipment control software, experience with the implementation of laboratory automation in regulated analytical laboratories, as well as good organization/communication skills. Specifically, as our laboratories advance towards automation, digitalization, and full adoption of enterprise platforms including automated data capture and electronic notebooks.
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 for the department; resolve issues related to data management systems in collaboration with IS and external vendors.
- Collaborate with IS, Digital, and external vendors for the development, configuration, and implementation of computer-based system applications.
- Provide local IT support for lab infrastructure and equipment software applications.
Digital Transformation & Automation- Support the implementation of connected systems and automated data capture, including electronic signatures, digital audit trails, and automated notifications in accordance with GxP requirements.
- Serve as a key point person for implementation of systems for equipment lifecycle management, maintenance tracking, and resource management within the Sanofi laboratory workflow application.
- Support implementation of automation initiatives by partnering with the Automation, Digital and IS teams.
Compliance & Validation- Prepare User Requirement Specifications (URS), Impact assessments, Lab Instrument Audit Trails, Deviations, change controls and risk analyses for new or modified equipment/software.
- Author SOPs and training materials related to data management and digital workflows.
- Support Computer System Validation (CSV) activities in partnership with Validation teams.
- Collaborate with Quality Assurance teams to uphold data integrity standards and ensure audit readiness.
- Share on-call duties for Environmental Monitoring System (EMS) for GMP equipment.
Cross-Functional Collaboration- Serve as the liaison between Operations, Validation, QA, Digital/IS, and external vendors.
- Facilitate training and drive adoption of new digital tools across the team.
Modernization & Continuous Improvement- Evaluate emerging tools and industry best practices relevant to analytical laboratory operations.
- Support change management activities associated with digital transformation initiatives.
About youMain Qualifications:
- Master's Degree in Biology, Chemistry, Biochemistry, Analytics Chemistry, data management, Laboratory Informatics, Information Systems / Information Technology or related and >2 years of relevant experience, or Bachelor's Degree in Biology, Chemistry, Biochemistry, Analytics Chemistry, data management, Laboratory Informatics, Information Systems / Information Technology or related and >4 years of relevant experience.
- Minimum 3 years of experience in a cGMP environment
- Strong organizational and communication skills with the ability to manage cross-functional stakeholders.
- Ability to work independently and manage multiple priorities effectively.
- Demonstrated experience with laboratory data management systems (ECM, or equivalent).
Preferred Qualifications:
- Experience with Biovia automated laboratory workflows or equivalent laboratory digitalization platforms
- Familiarity with CSV principles and regulatory frameworks (FDA 21 CFR Part 11)
- Knowledge of data integrity requirements in a GMP environment
The salary range for this position is:
$85.500,00 - $123.500,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
