MES Engineer II

Job Title: MES Engineer II

Department: Digital Operations Technology

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Position Overview with Key Responsibilities

The primary responsibilities will be with the Manufacturing Execution System (MES) 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.

Responsibilities include:

• 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.

• Production:

  • 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.

• Safety:

  • Complying with requirements from Sanofi'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.

  • 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.

About you

Basic Qualifications

• Bachelor’s degree in Engineering, Science and 3 to 5 years relevant work experience or 7 years of relevant work experience.

• Minimum of 2.5 years of electronic batch record development experience with Werum-Koerber PASX/Emerson/Siemens/Rockwell MES system

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

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

Preferred Qualifications

• MES Werum-Koerber PAS-X batch record editing experience.

• Experience in OSI PI system maintenance and configuration activities

• Experience with DCS systems

• Experienced in establishment of safe practices in a cGMP environment.

• Proficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, SQL, 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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