Senior MES Solution Architect

The Senior Solution Architect leads the design and evolution of FUJIFILM Biotechnologies' global digital manufacturing architecture, including ISA-88/95-aligned capabilities across OT, automation, and manufacturing systems (e.g., DCS, MES, SCADA, data historians) and integrations to enterprise platforms. The role owns the development and lifecycle of reference architectures, drives governance and standards, and steers complex solution decisions balancing compliance, risk, cost, performance, and sustainability. Operating with minimal supervision, this role influences cross-functional stakeholders, mentors engineers and operations teams, and enables scalable, compliant solutions as sites move from project phase to steady-state operations.

What you’ll do

• Architect end-to-end solutions across MES/MOM, DCS/PLC/SCADA, historians (e.g., OSIsoft PI), and integrations to ERP/LIMS/data platforms.
• Lead Recipe-Driven Operations (ISA‑88) design and implementation for small-scale sites and define scale-out patterns for future sites.
• Define and maintain reference architectures, standards, and governance; present designs to architecture and design review boards.
• Drive structured option analysis and decisions (cost, risk, compliance, sustainability); document assumptions and trade-offs.
• Ensure compliance with GMP, data integrity (ALCOA ), CSV/CSA, and cybersecurity controls (e.g., IEC 62443 principles).
• Identify and manage architectural risk, technical debt, and deviations; propose and track mitigations to closure.
• Partner across Automation/OT, IT, Manufacturing Operations, Quality/Validation, Cybersecurity, and Enterprise Architecture.
• Guide vendors and system integrators; align deliverables to standards, SLAs, and quality expectations.
• Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets.

What you’ll bring

• Education: Bachelor’s degree in Chemical/Electrical/Mechanical/Computer/Systems Engineering or related field; or equivalent experience. Master’s degree preferred.
• Experience: 8 years related experience (or 6 with a Master’s; or PhD with 3 ), including 5 years in IT/digital/automation/engineering roles supporting manufacturing in regulated industries (biopharma/medical device/industrial).
• Architecture depth: Proven design and implementation aligned to ISA‑88/ISA‑95 (ISA‑18.2 advantageous), spanning OT systems and enterprise integration.
• Compliance and security: Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in-depth).
• Integration and data: Familiar with integration patterns (APIs, eventing/message buses), cloud/edge patterns for manufacturing data, and models enabling analytics.
• Communication: Clear, persuasive communicator with the ability to influence decisions across diverse technical and business stakeholders.

Nice to have

• Experience with global MES/MOM, historian/PI, SCADA/DCS programs or platform rollouts.
• Exposure to IEC 62443 controls, Annex 11/21 CFR Part 11, and validation documentation standards.
• Vendor/SI oversight experience (architecture reviews, SoW validation, delivery assurance).

Help build the digital backbone of biomanufacturing. At FUJIFILM Biotechnologies, you will lead the architecture that powers our global manufacturing network—shaping resilient, compliant, and scalable solutions that ultimately help our partners bring life-changing therapies to patients faster.

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time,and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

This is a global position that will support all our FUJIFILM Biotechnologies sites.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee atFUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for thisrequisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of anykind will be paid.