MES Specialist - GMP and EBR Support

BioSpace; Swiftwater (Monroe County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14 weeks)

Job summary

Sanofi in Swiftwater, PA is seeking an MES Specialist to join the Manufacturing Systems & Automation team. You will support the MES/EBR space, configure Siemens OpCenter, and assist with new product deployments, testing, and on-call support for production operations.

You'll collaborate with Quality, Facilities, Tech Transfer, and Supply Chain to document requirements, validate changes, and ensure GMP compliance. Strong automation experience and cross-functional communication are essential.

Qualifications

• 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.

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.
• Collaborate with procurement and project teams to select vendors for manufacturing systems and automation.
• Identify and proactively manage risks and ensure compliance with GMP to minimize disruptions to timelines and costs.
• Develop and deliver training materials for operations staff and provide ongoing support post-implementation.
• Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer to document detailed requirements and perform MES support.
• Develop standards and best practices for development and validation activities and lead design reviews.

Skills

MES Platform Configuration (Siemens Op

Electronic Batch Record (EBR) Support

DCS/SCADA Systems (DeltaV, Aveva)

OPC & Data Integration (Historian, ERP

Education

Bachelor's degree in engineering or related field

Tools

Siemens OpCenter

DeltaV

Aveva

Job description

Sanofi in Swiftwater, PA is seeking an MES Specialist to join the Manufacturing Systems & Automation team. You will support the MES/EBR space, configure Siemens OpCenter, and assist with new product deployments, testing, and on-call support for production operations.

You'll collaborate with Quality, Facilities, Tech Transfer, and Supply Chain to document requirements, validate changes, and ensure GMP compliance. Strong automation experience and cross-functional communication are essential.