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A Range of Possibilities

MES Engineer III

date posted 09/03/2022
contract type Full time
job id R2658371
location Framingham, Massachusetts

**This role will be supporting multiple buildings within our new 'green' Framingham, MA facility**

**Manufacturing Execution System**

**Open to those with Emerson Syncade, Siemens Op-Center, or Rockwell- FactoryTalk Production Centre software experience**

**Great promotion opportunity to the next Engineering Level**

**Hybrid Remote**

POSITION OVERVIEW

The Digital Operations Technology (DOT) 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, DOT 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 DOT commissioned/qualified/validated state and the retirement of the system at the end of DOT life. Additionally, through daily tasks, DOT 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 DOT group. Additionally, the DOT group continues to progress DOT 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. This position is responsible for mentoring and leading other junior MES engineers.

Responsibilities include:

MANAGEMENT

oProviding leadership and direction to support teams while embodying the principles of the Sanofi Global Leadership Model

oDeveloping colleagues by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance

oEnsuring timely issue escalation to manufacturing senior management and cross-functional support teams

oPartnering 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.

oEnsuring that appropriate levels of trained resources are available to meet production schedules.

oEnsuring that a consistent technical approach for EBR development across Projects in Framingham.

oMentor MES Engineers to ensure that the team applies compliant, efficient engineering solutions to projects

PROBLEM SOLVING

oProvide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. 

oSolutions are imaginative, thorough, practical, and consistent with organization objectives.

PRODUCTION

oResponsible for ensuring MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements.

oManaging small to medium projects related to MES and ensuring that the appropriate controls, approvals, and validation requirements are implemented.

TRANING /DEVIATIONS/COMPLIANCE

oComplying with Sanofi requirements for training, maintaining training at or above 95% on time.

oUtilizing quality systems to measure, analyze, and improve team performance.

oLeads staff meetings, providing updates of department activities and project statuses. 

oEnsuring that Process, Equipment and MES documentation is compliant and inspection ready.

oParticipating in inspections conducted by external regulators.

oPartnering with direct and indirect management chain to ensure the following:

oDesigning Department Training Plan and managing execution.

oEnsuring Inspection Readiness of assigned areas.

oOverseeing completion of investigations and deviations.

SAFETY

oComplying with requirements from Sanofi's Safety Program including Health and Safety regulations and OSHA requirements.

CONTINOUS IMPROVEMENT

oWorking collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner.

oIdentifying opportunities to improve manufacturing processes and practices.

oEnsuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate.

oPartnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process.

oPartnering with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM in their area of responsibility.

oEnsuring that internal customers and suppliers are aligned with the solutions and services of the department.

PARTNERING WITH QA TO ENSURE THE FOLLOWING:

oEnsuring all deviations and CAPA’s are closed in a timely manner

oProviding oversight for deviations and department documentation changes.

oParticipating in inspections conducted by external regulators

oComplying with requirements from Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements

LEADING PEOPLE

oSanofi’s leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.

LEADING THE BUSINESS

oSanofi’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.

DELIVERING TO CUSTOMERS

oSanofi’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.

Basic Qualifications:

oBachelor’s degree in Engineering, Science and 5 to 7 years relevant work experience or 11 years of relevant work experience.

oMinimum of 5 years of electronic batch record development experience with Werum/Emerson/Siemens/Rockwell MES system

oDirect experience with regulated environments (i.e. cGMP, OSHA, EPA).  

oDemonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.

Preferred Qualifications:

oMaster’s with 4 to 5 years of relevant work experience.

oMES Werum PAS-X batch record editing experience.

oExperienced in establishment of safe practices in a cGMP environment.

oProficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, etc.

Special Working Conditions:

oRequired manufacturing operations support on a rotating “on call” 24/7 basis.

oRequires working in an industrial manufacturing environment including gowning.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

Sanofi Inc. and DOT 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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PDN

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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