Sanofi Group Senior Automation Engineer 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.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
This position is responsible for mentoring and leading junior Automation Engineers and providing Automation expertise for medium to large projects. This person will design, architecture, troubleshoot, and deliver future enhancements for Automation related systems. The person will be responsible for maintaining and providing technical support, ensuring availability of the automation systems for multiple manufacturing facilities.
Additional Responsibilities include:
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.
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
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
Participating in staff meetings, providing updates of department activities and project statuses.
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
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.
Complying with requirements from Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements
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 Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM.
Ensuring that internal customers and suppliers are aligned with the solutions and services of the department.
Providing leadership and direction to support teams while embodying the principles of the Sanofi Global Leadership Model
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 team members 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.
Mentoring Automation Engineers to ensure that the team applies compliant, efficient engineering solutions to projects.
Delivering to Customers
Sanofi’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals. They create a vision for the organization while continuously improving operations by holding teams accountable to high standards of performance.
Bachelor’s degree in Engineering, Science or related technological field or 9 years of relevant work experience, or
Master’s with 7 years of relevant work experience
Experience with at least one computerized system (Werum PAS-X, DeltaV, PI, etc.)
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.
Experience with multiple computerized systems (Werum PAS-X, DeltaV, PI, etc.)
Experience with SCADA/PLC systems such as Rockwell Factory Talk/RSLogix
Experience with systems/network/validation, preferable in the chemical, pharmaceutical, foods, or other process industries is preferred
Electrical Engineer or Chemical Engineer
Experienced in establishment of safe practices in a CGMP environment.
Proficient working with computer programs/applications such as Windows XP, Windows 7, VBA, MS Word, Excel, Access, etc.
Strong organizational skills
Self-motivated with the ability to working independently and manage multiple projects
Proven technical and analytical skills to quickly resolve automation system issues.
Special Working Conditions
Required manufacturing operations support on a rotating “on call” 24/7 basis
Requires working in an industrial manufacturing environment including gowning.
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.