Hybrid MES & Industry 4.0 Architect at JSat Automation

JSat is currently looking for a MES & Industry 4.0 Architect to fill a role in our Concord, MA office. This position will drive the technical strategy, architecture, and design of MES and digital manufacturing systems for our clients. This role is ideal for someone who thrives at the intersection of manufacturing operations, automation, and digital transformation. You will work with cross-functional teams to deliver innovative and validated solutions aligned with ISA-95, GAMP, and Industry 4.0 standards. 

Key Responsibilities 

Solution Architecture 

• Lead the design and architecture of MES and connected systems for client sites in life sciences, F&B, medical devices and other industries.
• Define end-to-end architecture including MES, SCADA, PLC, ERP, LIMS, historian, and cloud/edge layers.
• Develop technical documentation such as solution blueprints, architecture diagrams, interface specs, and data flow models.

Client Engagement & Delivery 

• Serve as a technical leader in customer engagement, understanding client processes, pain points, and transformation goals.
• Work within a multi-disciplinary team to develop proposals based on customer-specific requirements and industry regulations.
• Translate functional/business requirements into scalable MES and automation solutions.
• Establish, develop, and maintain strong relationships with prospects and client stakeholders across manufacturing, quality, and regulatory functions
• Collaborate with project managers, validation leads, automation engineers, and developers to ensure successful project delivery.

Integration & Industry 4.0 Enablement 

• Architect integration of MES with upstream (ERP, PLM) and downstream (SCADA, IoT, QA) systems using OPC UA, REST APIs, MQTT, etc.
• Lead the adoption of Industry 4.0 enablers such as digital twins, edge computing, real-time analytics, AI/ML, and mobile-enabled MES.
• Design hybrid on-prem/cloud data strategies that meet regulatory and performance requirements.
• Collaborate with clients to identify engineering challenges in areas such as recipe design and management, overall equipment effectiveness (OEE), data collection and architecting solution, batch and material tracking, and batch release process and define, implement solutions through projects.

Compliance & Validation 

• Ensure solutions are compliant with 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity guidelines.
• Support CSV documentation lifecycle, including URS, FRS, risk assessments, and IQ/OQ documentation.
• Work closely with QA and client validation teams to align architecture with audit readiness requirements.

Team Development & Innovation 

• Mentor junior MES engineers and support internal knowledge-sharing initiatives.
• Contribute to reusable templates, tools, and accelerators for MES and industry 4.0 implementation.
• Stay up to date with emerging technologies, tools, and industry best practices.

Qualifications 

Education 

• Bachelor’s or Master’s degree in Engineering, Computer Science, Automation, or a related field.

Experience 

• 12+ years in MES architecture, digital manufacturing, or industrial automation.
• Experience working in or with system integrators or automation consulting firms.
• Experience working with at least one large US based Pharma Manufacturer.
• Hands-on expertise with MES platforms such as Werum PAS-X, Rockwell PharmaSuite, Emerson Syncade, Tulip, or Siemens Opcenter.
• Solid understanding of ISA-95, ISA-88, batch processing, and GMP/GxP manufacturing.
• Experience in regulated environments (FDA, USDA, EU) in pharma, biotech, med device, or food.
• Familiarity with PLC/SCADA systems (Rockwell, Siemens, DeltaV, etc.).
• Working knowledge of cloud platforms (AWS, Azure) and IIoT platforms.
• API integration, data modeling, and industrial communication protocols.
• Agile delivery in a validated environment.
• Certifications in MES platforms or cloud architecture a plus.

Soft Skills 

• Excellent verbal and written communication skills for both technical and non-technical audiences.
• Strong problem-solving ability and attention to detail.
• Comfortable presenting to customers and leading architectural discussions.
• Team player who can work cross-functionally in matrixed project environments.

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