Senior Automation Engineer

Summary: The Senior Automation Engineer provides technical support and accountability for the execution of capital projects that are critical to the success of our business. The Senior Automation Engineer will participate in the development, installation, operation, maintenance, and repair of all FUJIFILM Diosynth Biotechnologies Texas automation systems to meet organizational goals and objectives. This position will also work closely with other operators, calibration technicians and engineers to maintain complex systems.

Functions:

• Ensure compliance with regulations (e.g., 21 CFR Part 11, cGMP) during validation processes.

• Integrate GMP-compliant systems with Corporate IT infrastructure.
• Participate in system development and design.
• Provide daily support for Building Management and Process Control Systems.
• Perform coding, programming, and configuration for control systems.
• Configure and maintain DeltaV Batch recipes, virtualization, and OSI Soft PI Historian.
• Transfer technologies, recipes, and parameters to commercial manufacturing.
• Maintain specifications and documentation for automation systems.
• Develop and maintain SOPs and training for automation systems.
• Execute Engineering Test Plans and Software Test Specifications.
• Support and maintain automation reporting systems like Infobatch.
• Maintain backups of automation code.
• Review new equipment purchases and conduct design reviews, FAT, and SAT.
• Ensure compliance with cGMP practices in manufacturing environments.
• Perform duties in a compliant and ethical manner.
• Perform other duties as assigned.

Required Skills & Abilities:

• Knowledge of Weight and Dispense and Electronic Batch Record (EBR) systems.
• Experience with SCADA design, implementation, and operation.
• Ability to develop new code for continuous and batch control systems.
• Expertise in BMS, SCADA, and DCS design, commissioning, and validation in a GMP facility.
• Familiarity with GAMP, SDLC approaches, and CAPA.
• Knowledge of 21 CFR Part 11 compliance.
• Understanding of HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, and Modbus TCP/IP.
• Proficiency with DCS, SCADA, and BMS systems such as DeltaV, FactoryTalk View, APOGEE.
• Reliable, self-motivated, and team-oriented with a positive attitude.
• Ability to work effectively with minimal supervision in a dynamic work environment.
• Strong ability to manage time and prioritize tasks to meet tight timelines and shifting priorities.
• Excellent written, verbal, and interpersonal communication skills.
• Strong attention to detail with the ability to draft and correct preventative maintenance procedures for technical equipment.
• Working knowledge of MS Office products (Word, Excel, Outlook, PowerPoint).

Requirements

Qualifications:

• Bachelor’s Degree preferably in Chemical, Electrical, Mechanical Engineering or with five (5) years of relevant automation engineering experience preferably in the biotechnology /pharmaceutical industry.
• Experience with critical utility and non-GMP utility systems a plus.