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Senior Automation Engineer, MES (PAS-X)

FUJIFILM Diosynth Biotechnologies
Holly Springs, NC Full Time
POSTED ON 4/1/2025
AVAILABLE BEFORE 4/30/2025

Senior Automation Engineer 1, MES (PAS-X)

Company: FUJIFILM Diosynth Biotechnologies

Type: Full-Time


About the Role

FUJIFILM is seeking a Senior Automation Engineer 1, MES to support the Drug Product Finished Goods Manufacturing (DPFG) facility. This role involves leading the design, integration, and optimization of automation systems while ensuring compliance with Good Manufacturing Practices (GMP). You will play a key role in driving innovation, managing complex projects, and collaborating with cross-functional teams to deliver high-quality results.


Key Responsibilities

  • Lead the design and integration of OEM equipment for formulation, filling, and automated inspection processes into site infrastructure.
  • Manage automation projects, ensuring delivery within budget, timelines, and quality standards.
  • Integrate and synchronize MES systems (e.g., PAS-X) with production equipment and infrastructure.
  • Oversee automation testing during FAT, commissioning, and site validation activities.
  • Lead change control processes and ensure compliance with GMP regulations.
  • Develop and mentor engineers, fostering technical excellence and continuous learning.
  • Stay current with industry trends, recommending improvements for cutting-edge automation capabilities.
  • Author and update technical documentation, including URS, FS, and DQ.
  • Provide on-call support for automation troubleshooting and inquiries.
  • Collaborate with Manufacturing, Maintenance, and Validation teams to ensure seamless operations.
  • Conduct training sessions and present technical information to stakeholders.


Knowledge and Skills

  • Advanced problem-solving and troubleshooting skills for complex automation systems.
  • Effective written and oral communication for cross-functional collaboration.
  • In-depth knowledge of regulatory and quality requirements in manufacturing (GMP compliance).
  • Proficiency in Siemens PLC/HMI programming, AVEVA (Wonderware) SCADA, AVEVA PI Historian, and PAS-X.
  • Experience with computer networking, switches, and communication troubleshooting.


Basic Requirements

  • Bachelor’s degree in Automation, Instrumentation & Controls, or related technical field with 8 years of experience.

OR

  • Master’s degree in Automation, Instrumentation & Controls, or related technical field with 6 years of experience.
  • Proven experience with MES systems and OEM equipment integration.


Preferred Qualifications

  • Expertise in PAS-X technologies.
  • Prior experience in pharmaceutical or GMP manufacturing environments.
  • Strong track record of managing vendors and contractors to ensure quality project deliverables.


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