MES Specialist

Main Responsibilities:

• Oversee manufacturing execution system (MES) and automation within the whole site.

• Develop MES/Electronic Batch Record (E ) solutions, including recipe and configuration/system changes, to meet business requirements.
• Ensure system integration with digital applications supporting production, quality control, and data management.
• Ensure GMP and regulatory compliance (C&Q): develop specifications, test protocols, and support system validation; tailor strategies via site assessments.
• Coordinate with procurement and project teams to select manufacturing systems/automation vendors aligned to quality and regulatory standards.
• Identify and proactively manage risks; maintain GMP compliance to minimize timeline/cost disruptions.
• Develop and deliver training for operations staff; provide ongoing post-implementation support and mentorship for new MES Specialists.
• Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer to capture/document requirements; provide MES application support as needed.
• Develop best practices/standards; lead design reviews and user acceptance testing during change/validation.
• Plan, develop, peer review, test, and implement recipe creation/modification and other MES changes.
• Participate in facility operational meetings to meet reporting needs.
• Provide rotating on-call support during off-shift hours.

• Bachelor’s degree in engineering (Electrical/Chemical/Mechanical/Automation), Computer Science, Biotechnology, Health Sciences, or related biopharma field.
• 1+ years’ experience supporting MES/E  and automation in biopharma or related industries.

• Hands-on MES Siemens OpCenter; DCS (DeltaV), SCADA (Aveva), PLCs.
• Familiarity with process control systems (DeltaV, Aveva, PLCs).
• Machine connectivity/data acquisition from PLCs to Historian/ERPs using technologies such as OPC.

• MES platform configuration (Siemens OpCenter); E  support; DCS/SCADA (DeltaV, Aveva); OPC/data integration (Historian, ERP connectivity).

• Technical/project leadership, collaboration, analytical skills, and communication with cross-functional teams.