MES & Industry 4.0 Architect

JSat an E Tech Group Company; Concord (NH); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading automation solutions provider seeks an MES & Industry 4.0 Architect to drive technical strategy and design of digital manufacturing systems. The ideal candidate has over 12 years of experience in MES architecture and strong expertise with various automation platforms. This full-time role includes mentoring junior engineers and ensuring regulatory compliance, offering a chance to lead innovative solutions.

Qualifications

• 12+ years of experience in MES architecture, digital manufacturing, or industrial automation.
• Experience in regulated environments (FDA, USDA, EU) in pharma, biotech, medical devices, or food.
• Certifications in MES platforms or cloud architecture are a plus.

Responsibilities

• Lead the design and architecture of MES and connected systems.
• Ensure solutions are compliant with 21 CFR Part 11 and GAMP 5.
• Mentor junior MES engineers and support internal knowledge-sharing.

Skills

12+ years in MES architecture

Experience with system integrators

Hands-on expertise with MES platforms

Strong understanding of ISA-95

Excellent verbal and written communication

Strong problem-solving ability

Education

Bachelor’s or Master’s degree in relevant field

Tools

Werum PAS-X

Rockwell PharmaSuite

Emerson Syncade

AWS

Azure

Job description

Overview

Join to apply for the MES & Industry 4.0 Architect role at JSat Automation (an E Tech Group Company). This position is based in Concord, MA and drives the technical strategy, architecture, and design of MES and digital manufacturing systems for our clients. The role is ideal for someone who thrives at the intersection of manufacturing operations, automation, and digital transformation, working with cross-functional teams to deliver innovative and validated solutions aligned with ISA-95, GAMP, and Industry 4.0 standards.

Key Responsibilities

• Lead the design and architecture of MES and connected systems for client sites across industries such as life sciences, food & beverage, medical devices, and more.
• 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 with multi-disciplinary teams to develop proposals based on customer requirements and regulatory considerations.
• Translate functional/business requirements into scalable MES and automation solutions.
• Establish and maintain relationships with 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, and similar.
• Lead adoption of Industry 4.0 enablers such as digital twins, edge computing, real-time analytics, AI/ML, and mobile-enabled MES.
• Design hybrid on-premise/cloud data strategies meeting regulatory and performance requirements.
• Identify engineering challenges in areas such as recipe design and management, OEE, data collection, batch and material tracking, and batch release processes; define and 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 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 implementations.
• 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 with system integrators or automation consulting firms.
• Experience 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.
• Strong understanding of ISA-95, ISA-88, batch processing, and GMP/GxP manufacturing.
• Experience in regulated environments (FDA, USDA, EU) in pharma, biotech, medical devices, 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 are a plus.

Soft Skills

• Excellent verbal and written communication for 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.

Seniorities & Employment

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Design, IT
• Industries: Automation Machinery Manufacturing

Note: This refined description excludes unrelated job postings and retains the essential information about the MES & Industry 4.0 Architect role at JSat Automation.