Sanofi Group Computer System Validation Engineer II 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 the execution of compliance and validation activities in support of 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. This position will be responsible for the validation of computer systems including; testing of configuration in various shop floor and QC computerized systems, user access reviews for compliant user permissions and the development and execution of test scripts.
Additional responsibilities include:
Leadership: Ensuring timely issue escalation to Senior Management and cross-functional support teams. Partnering with support teams i.e., Manufacturing, Quality, etc. to ensure adherence to production schedules, while holding teams responsible for compliance to all safety and quality regulations. Ensuring that a consistent technical approach for Process Equipment Engineering and Automation is used across Projects.
Problem Solving: 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 completion. Utilizing quality systems to measure, analyze, and improve team performance. 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
Production: Responsible for ensuring computer systems are validated and maintain their validated state to support Operations Schedule Adherence requirements. Supporting or leading departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented.
Continuous Improvement: Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner Identifying opportunities to improve site processes and practices. Ensuring all site management tools/systems and documentation (SOPs, MBR's, OJTs) are 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 thi at 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 5 years of relevant work experience, or
Master’s or PhD with 3 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.
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