MES Specialist

Sanofi•Swiftwater, PA

1d•Onsite

About The Position

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

Requirements

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.
MES Platform Configuration (Siemens OpCenter)
Electronic Batch Record (EBR) Support
DCS/SCADA Systems (DeltaV, Aveva)
OPC & Data Integration (Historian, ERP connectivity)
Technical/Project Leadership
Team Collaboration
Analytical Skills
Communication (cross-functional teams; occasional stakeholder interaction)

Responsibilities

Develop MES/EBR solutions including recipe, configuration, and/or system changes to meet business requirements.
Ensure seamless integration of systems with digital applications to support production, quality control, and data management.
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.
Collaborate with procurement and project teams to select vendors for manufacturing systems and automation. Ensure alignment with project quality and regulatory standards.
Identify and proactively manage risks. Ensure compliance with GMP to minimize disruptions to timelines and costs.
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.
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.
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.
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.
Participate in facility operational meetings to ensure facility reporting needs are met.
Be available to provide “on call” support during off-shift hours, based on a rotating schedule, to support manufacturing operations.