Senior Automation Engineer

Fujifilm - College Station, TX

Full-time - Senior

College Station, TX

Machinery Manufacturing

About the position

The Senior Automation Engineer at Diosynth Biotechnologies plays a crucial role in providing technical support and accountability for the execution of capital projects that are vital to the success of the organization. This position involves participating in the development, installation, operation, maintenance, and repair of all automation systems at the Texas facility. The Senior Automation Engineer will work closely with operators, calibration technicians, and engineers to ensure the smooth operation of complex systems, contributing to the overall goals and objectives of the organization. In this role, the engineer will serve as a Subject Matter Expert (SME) for validation processes, ensuring compliance with regulations such as 21 CFR Part 11 and current Good Manufacturing Practices (cGMP). The engineer will interface with IT to ensure that the integration of systems is compliant with corporate IT infrastructure. Responsibilities include preparing and participating in system specification development and design, providing daily support for Building Management Systems and Process Control Systems, and coding, programming, and configuring both continuous and batch controls. The Senior Automation Engineer will be responsible for DeltaV Batch recipe configuration, phases, and equipment management, as well as the DeltaV Virtualization and OSI Soft PI Historian configuration and maintenance. The role also involves maintaining Functional Specifications, Database Design Specifications, and Hardware Design Specifications for automation systems, developing and maintaining Automation Standard Operating Procedures, and performing Engineering Test Plans for Automation. The engineer will execute Software Test Specifications, maintain backups of automation code, and provide engineering and technical reviews of new equipment purchases. All duties must be performed in a compliant and ethical manner, adhering to applicable laws, regulations, and industry codes, particularly in the context of bulk drug and vaccine manufacturing.

Responsibilities

• Support validation as the Subject Matter Expert to ensure compliance with regulations (e.g. 21 CFR Part 11 and cGMP).
• Interface with IT to ensure GMP-compliant integration with Corporate IT infrastructure.
• Prepare, assist, and participate in system specification development and design.
• Provide daily support on Building Management Systems and Process Control Systems.
• Code, program, and configure for continuous and batch controls.
• Responsible for DeltaV Batch recipe configuration, phases, and equipment management.
• Develop procedures to transfer technologies, recipes, and parameters from process development to commercial manufacturing.
• Responsible for DeltaV Virtualization and OSI Soft PI Historian configuration and maintenance.
• Maintain Functional Specifications, Database Design Specifications, and Hardware Design Specifications for automation systems.
• Develop and maintain Automation Standard Operating Procedures and training for Automation Systems.
• Perform Engineering Test Plans for Automation.
• Support, configure, and maintain automation reporting systems like Infobatch.
• Execute Software Test Specifications and maintain backups of automation code.
• Provide engineering and technical review of new equipment purchases, including Request for Quote Bid Packages, design review, FAT, and SAT.
• Perform all job duties and responsibilities in a compliant and ethical manner according to applicable laws, regulations, and industry codes.

Requirements

• Bachelor's Degree in Chemical, Electrical, Mechanical Engineering or closely related field.
• Five (5) years of relevant automation engineering experience, preferably in the biotechnology/pharmaceutical industry.
• Knowledge in Manufacturing Enterprise System including Weight and Dispense and EBR.
• Experience with Process Control System, SCADA design, implementation, and operation of systems.
• Ability to develop new code for continuous control and batch control.
• Experience with BMS, SCADA, and DCS design, commissioning, and validation in a GMP facility.
• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.
• Computer knowledge of 21 CFR Part 11.
• Understanding of automation protocols like HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, and Modbus TCP/IP.
• Experience with DCS, SCADA, and BMS systems such as DeltaV, Factory Talk View, APOGEE, etc.
• Strong written, verbal, and interpersonal communication skills with attention to detail.

Nice-to-haves

• Experience with critical utility and non-GMP utility systems.