Location
Framingham, MA | United States
Job description
Department Description:
The Framingham campus is home to Sanofi’s digital facility which won ISPE’s Facility of the Future and Facility of the Year 2020. As such, the Digital Operations Technology (DOT) group in Framingham is responsible for executing Sanofi’s Digital Strategy to deliver innovative solutions. Focused on Digital 4.0, this group is involved in delivering digital solutions for large capital projects as well as continuous improvement and optimizing existing solutions. The Digital Operations Technology group is responsible for design, implementation, support, and maintenance of digital systems aligned with site and company goals. The Digital Operations Technology group is responsible for maintaining stable, qualified, and highly available computing infrastructure and digital software applications. This encompasses work processes that originate with the identification of a new or revised digital systems, 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.
Responsibilities:
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 providing MES expertise for medium to large projects. These projects include continuous improvement, retrofit, and large capital investments to optimize manufacturing and supporting operations. This person will design, architect, troubleshoot, and deliver future enhancements for MES related systems.
The MES Engineer Senior will be responsible for using expertise to design innovative solutions. These solutions span the areas of MES Electronic batch records (EBR’s), systems, data historians, IoT devices, etc. with a key focus on pushing new boundaries of Digital 4.0. The person will be responsible for maintaining and providing technical support, ensuring availability of the MES systems for multiple manufacturing facilities.
Additional Responsibilities include:
Leadership:
Providing leadership and direction to junior team members while embodying the principles of the Sanofi Global Leadership Model
Leading MES related projects
Managing contractors for staff augmentation or project roles
Ensuring timely issue escalation to senior management and cross-functional support teams
Partnering with support teams i.e., Manufacturing, Quality, etc to ensure deliverables are completed to meet to production schedules
Mentoring junior MES engineers to ensure that the team applies compliant, efficient solutions to projects
MES:
Provide technical solutions to a wide range of MES EBR related design challenges. Solutions are imaginative, thorough, practical, and consistent with organization objectives
Responsible for ensuring MES EBR’s and MES Systems are available to support operations.
Managing medium to large departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented
Integrate systems and data from a variety of skidded systems, analytical equipment, and process/building control systems
Developing robust solutions that have minimal downtime and ensure data integrity
Lead development of MES standards
Training /Deviations /Compliance/Safety:
Complying with Sanofi requirements for training
Ensuring Inspection Readiness of assigned areas
Overseeing completion of investigations and deviations
Ensuring all assigned deviations and CAPA’s are closed in a timely manner
Ensuring that MES 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
Continuous Improvement:
Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner
Partnering with Manufacturing to troubleshoot and drive resolution of MES execution issues and proactively driving projects to improve/enhance MES EBR’s in support of MFG day to day activities
Partnering with Operational Excellence to drive process improvements through Kaizens, Kanban, 5S and VSM
Basic Qualifications
Bachelor’s degree in Engineering, Science or related technological field and 8+ years of experience
Minimum of 6 years of electronic batch record development experience with Koerber/Werum/Emerson/Siemens/Rockwell MES system
3+ years of hands-on technical experience with troubleshooting and root cause analysis for issues with MES Batch records, MES systems
3+ years of hands-on technical experience with providing support for automated manufacturing operations
Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments
Preferred Qualifications
Experience with DeltaV
Experience with Aveeva/OSI PI
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 , SQL , VBA, MS Office applications, etc.
Strong organizational skills
Self-motivated with the ability to work independently and be accountable
Proven technical and analytical skills to quickly resolve MES issues
Experience delivering solutions based on Digital 4.0
Experience with SaaS solutions
Experience with IoT solution and edge devices
Special Working Conditions
Required manufacturing operations support on a rotating “on call” 24/7 basis
Requires working in an industrial manufacturing environment including gowning
Hybrid role with 3 days a week onsite
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.
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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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