Sanofi Group MES 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. The group is also responsible for implementing and advancing Digital technologies to be at the forefront of Industry 4.0. 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. The primary responsibilities will be with the MES team but may require cross-training with other groups within the ITS group. Additionally, the ITS group continues to progress its Digital offerings in continued support of advanced manufacturing operations. This role will support these digital efforts.
This position will be an Electronic Batch Record designer for the Manufacturing Execution System (MES). Primary responsibilities include developing innovative, flexible, and robust batch records. Close collaboration with a cross-functional teams will be required to deliver batch records. The person will be responsible for maintaining and providing technical support for and ensuring availability of the MES and associated batch records for multiple manufacturing facilities. The person will also provide expertise with the MES system to enhance a digital, integrated shop floor. The person will provide batch record configuration expertise to develop complex and novel solutions as required. An understanding of automation, manufacturing processes, and ERP will be required to be successful in this role.
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 MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements.
Managing small to medium projects related to MES 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.
Participate in staff meetings, providing updates of department activities and project statuses.
Ensuring that Process, Equipment and MES 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 Sanofi'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 in their area of responsibility.
Ensuring that internal customers and suppliers are aligned with the solutions and services of the department.
Bachelor’s degree in Engineering, Science and 3 to 5 years relevant work experience or 7 years of relevant work experience.
Experience with at least one computerized system (Werum PAS-X, DeltaV, PI, SAP, etc.).
Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).
Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.
Master’s with 2 to 3 years of relevant work experience.
MES Werum PAS-X batch record editing experience.
Experienced in establishment of safe practices in a cGMP environment.
Proficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, etc.
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.
- Sanofi Group Jobs