MES Specialist

Job Title: MES Specialist

Location: Swiftwater, PA

About the Job

In this role, you'll join the Manufacturing Systems & Automation department at our Swiftwater site, working directly with the site manufacturing execution system (MES) automation day to day support. This role will provide electronic batch record (EBR) support and configuration of the site MES. The role will support new product and process deployments as well as EBR revisions within the MES space in conjunction with several cross-functional departments. This includes implementation of changes to the EBR, interfaces, updating design documents, executing testing, troubleshooting events, and being a part of the MES on-call support.
 

 We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives

Main Responsibilities

 The MES Specialist will oversee manufacturing execution system and automation within the whole site.

 Key responsibilities include:

• MES Solutions: Develop MES/EBR solutions including recipe, configuration, and/or system changes to meet business requirements.

• System Integration: Ensure seamless integration of systems with digital applications to support production, quality control, and data management.

• Deliverable Accountability: Ensure compliance with GMP and regulatory standards (C&Q), including user/functional/detailed specification development, test protocols, and system validation. Work closely with the client to understand their needs and develop strategies tailored to their organization through site assessments.

• Vendor Coordination: Collaborate with procurement and project teams to select vendors for manufacturing systems and automation. Ensure alignment with project quality and regulatory standards.

• Risk and Compliance Management: Identify and proactively manage risks. Ensure compliance with GMP to minimize disruptions to timelines and costs.

• Training and Support: Develop and deliver specialized training materials for operations staff to ensure proper execution of systems. Perform regular training sessions with operations. Provide ongoing support post-implementation. Provide mentorship and training for new MES Specialists.

• Collaboration and Documentation: Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer departments to capture and document detailed requirements. Perform application support duties for the manufacturing execution system (MES) as needed.

• Standards and Best Practices: Develop standards and best practices for development and validation activities. Lead cross-functional teams through design reviews and user acceptance testing during the development change and validation process.

• Development and Implementation: Perform and communicate planning, development, peer review, and testing solutions for recipe creation and modification. Execute development and implementation of new changes across the Manufacturing systems based on requirements, specifications, and developed software solutions.

• Operational Meetings: Participate in facility operational meetings to ensure facility reporting needs are met.

• On-Call Support: Be available to provide “on call” support during off-shift hours, based on a rotating schedule, to support manufacturing operations.

About You

Basic Qualifications

Education:

• Bachelor’s degree in engineering, Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, Health Sciences, or a related field in the biopharma sector.

• 1+ years of experience in MES/eBR and Automation support within biopharma or related industries.

• Hands-on experience and skill in MES​ Siemens OpCenter with strong expertise with DCS (DeltaV), SCADA (Aveva), PLCs, and related automation technologies in a manufacturing context.

• General knowledge/familiarity with Process Control Systems: DCS (DeltaV), SCADA (Aveva), PLCs

• Machine connectivity experience with data acquisition from PLCs into higher level applications like Historian, ERPs, etc.. using current technologies like OPC.

Technical Skills:

• MES Platform Configuration (Siemens OpCenter)

• Electronic Batch Record (EBR) Support

• DCS/SCADA Systems (DeltaV, Aveva)

• OPC & Data Integration (Historian, ERP connectivity)

Soft Skills:

• Technical/Project Leadership

• Team Collaboration

• Analytical Skills

• Communication (cross-functional teams; occasional stakeholder interaction)

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.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

North America Applicants Only

The salary range for this position is:

$85.500,00 - $123.500,00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.