Sanofi Group Computer Systems Validation Engineer III in Framingham, Massachusetts
The Information Technology & Solutions (ITS) Group is responsible for design, implementation, support, and maintenance of Information Technology solutions in support of site goals and objectives. In such, ITS Group is responsible for maintaining a stable, Qualified, and highly available computing infrastructure and implementation and Validated computer systems. This encompasses work processes that originate with the identification of a new or revised system, the design, installation, verification and validation of the system, the maintenance of the system in its commissioned/qualified/validated state and the retirement of the system at the end of its life. Additionally, through daily tasks, ITS supports current project operations and ensures compliance with regulatory, corporate and site requirements .
This position is responsible for mentoring and leading compliance and validation staff and supports laboratory systems management, system maintenance, troubleshooting, and future enhancements. The person will be responsible for compliance reviews of computer systems (including process control, data acquisition, local and enterprise systems), providing technical support for laboratory equipment and managing staff performance against operational goals.
Additional responsibilities include:
Providing leadership and direction to support teams while embodying the principles of the Sanofi Global Leadership Model
Developing colleagues by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance
Ensuring timely issue escalation to manufacturing senior management and cross-functional support teams
Partnering with support teams i.e., Manufacturing, Quality, etc to ensure adherence to production schedules, while holding direct reports and teams responsible for compliance to all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet production schedules.
Ensuring that a consistent technical approach for Process Equipment Engineering and Automation is used across Projects at the Boston Hub.
Mentor Compliance Specialists to ensure that the team applies consistent, compliant solutions to projects.
Provide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practical, and consistent with organization objectives.
Training /Deviations /Compliance:
Complying with Sanofi requirements for training, maintaining training at or above 95% on time
Utilizing quality systems to measure, analyze, and improve team performance
Leads staff meetings, providing updates of department activities and project statuses.
Partnering with direct and indirect management chain to ensure the following:
Designing Department Training Plan and managing execution.
Ensuring Inspection Readiness of assigned areas
Overseeing completion of investigations and deviations
Partnering with QA to ensure the following:
Ensuring all deviations and CAPA’s are closed in a timely manner
Providing over sight for deviations and department documentation changes.
Ensuring that Process, Equipment and Automation documentation is compliant and inspection ready.
Participating in inspections conducted by external regulators
Complying with requirements from Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements
Responsible for ensuring Process Equipment and Automation are available to support Operations Schedule Adherence requirements.
Overseeing departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented
Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner
Identifying opportunities to improve manufacturing processes and practices
Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate
Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process
Partnering with Lean Organization to drive business process improvements through Kaizens, Kanban, 5S and VSM.
Ensuring that internal customers and suppliers are aligned with the needs and services provided by the Manufacturing Engineering team
Bachelor’s degree in Engineering, Science or related technological field or 7 years of relevant work experience, or
Master’s or PhD with 5 years of relevant work experience
Experience with applications (DCS, MES, PI, Laboratory) and compliance (validation, auditing, tech writing)
Good understanding of Validation, SDLC (System Development Life Cycle) methodologies, System documentation including but not limited to user requirements, validation protocols, summary reports and standard operating procedures
Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).
Demonstrated knowledge of bus technologies and Instrumentation
Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments
Learning agility, problem solving skills and thought leadership
Electrical Engineer or Chemical Engineer
Implementation experience of software and hardware components within an FDA regulated environment.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.