Upstream Manufacturing Process Engineer I

Fujifilm - College Station, TX

Full-time - Entry Level

Remote - College Station, TX

Machinery Manufacturing

About the position

The Manufacturing Process Engineer I plays a crucial role within the Manufacturing Technical Operations department at FUJIFILM Diosynth Biotechnologies, located in College Station, Texas. This position is designed for individuals who are passionate about biotechnology and eager to contribute to the development of life-saving therapies. The engineer will work independently and collaboratively with colleagues to provide expertise in the design, development, standardization, and maintenance of operational biotechnologies used in the manufacturing of various proteins and drug substances. This role requires becoming a subject matter expert in core manufacturing technologies, including upstream and downstream processes such as cell culture, chromatography, and filtration technologies. In this position, the engineer will be responsible for developing and maintaining equipment and unit operation standards and procedures using the 4M approach (Man, Materials, Machinery, and Methods). This includes creating training programs for manufacturing technicians, collaborating with teams to enhance self-development plans, and interfacing with technical experts to stay informed about technology and regulatory issues impacting the biopharmaceutical industry. The engineer will also lead investigations into compliance issues, manage change in technology transfer practices, and ensure that training and skill-building activities align with site business requirements. The role involves understanding process control and material inputs to ensure acceptable process outputs, reviewing equipment qualification limits, and coordinating validation and calibration of manufacturing lab equipment. The engineer will also be tasked with developing and maintaining technical operational manuals, standard operating procedures, and batch records, while ensuring compliance with EHS and cGMP standards. This position is integral to the successful transfer and scaling of new processes into the manufacturing plant, requiring strong leadership, communication, and organizational skills.

Responsibilities

• Provide expertise and assistance for the design, development, standardization, and maintenance of operational biotechnology.
• Become the subject matter expert on core manufacturing and operational technologies.
• Create training programs and perform training for manufacturing technicians.
• Develop and maintain equipment and unit operation standards and procedures using the 4M approach.
• Collaborate with technicians and managers on self-development plans.
• Interface with internal/external technical experts to maintain knowledge of technology and regulatory issues.
• Specify, purchase, design, qualify, and hand over effective manufacturing systems.
• Implement various training methods including e-learning and classroom training.
• Investigate and resolve compliance issues that arise during manufacturing processes.
• Assist in identifying improvements to technology transfer practices for continuous improvement.
• Create and maintain technical training manuals and personnel certification processes.
• Ensure training and skill-building activities align with site business requirements.
• Review and approve equipment qualification limits and calibration tolerances.
• Coordinate validation, calibration, and PM completion of manufacturing lab equipment.
• Develop and maintain Technical Operational Manuals, SOPs, and Batch Records.
• Lead operational technology standardization and continuous improvement initiatives.

Requirements

• Bachelor's degree in Science, Engineering, or related field and one year of biotech manufacturing experience; OR an Associate degree with two years of experience; OR a High School/GED with four years of experience.
• One year of GMP experience is required.
• Excellent oral and written communication skills.
• Strong leadership skills and ability to train others to perform to cGMP standards.
• Proficient with Microsoft Office applications.
• Good self-discipline and attention to detail; ability to work under minimal supervision.
• Experience working in cleanroom environments under sterile or aseptic conditions.

Nice-to-haves

• Previous Process Engineering experience.
• Experience in developing training materials.
• Experience conducting and evaluating training.
• Experience with laboratory and manufacturing instruments/equipment.
• Previous leadership roles.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling options