Manufacturing Process Engineer II

Fujifilm - College Station, TX

Full-time - Mid Level

Remote - College Station, TX

Machinery Manufacturing

About the position

The Manufacturing Process Engineer II plays a crucial role in the Manufacturing Technical Operations department at FDB in College Station, Texas. This position is responsible for providing expertise in the design, development, standardization, and maintenance of operational biotechnologies used in the manufacturing of proteins and drug substances. The engineer will become a subject matter expert in core manufacturing technologies and will develop training programs for manufacturing technicians, ensuring compliance with industry standards and continuous improvement in manufacturing processes.

Responsibilities

• Develop and maintain equipment and unit operation standards and procedures using the 4M approach (Man, Materials, Machinery, and Methods).
• Create and deliver practical skill-building and training plans for operational technologies to manufacturing technicians.
• 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 sessions.
• Investigate and resolve compliance issues that arise during manufacturing processes.
• Identify improvements and manage changes in technology transfer practices.
• Create and maintain technical training manuals and personnel certification processes.
• Ensure training activities align with site business requirements.
• Review and approve equipment qualification limits and calibration tolerances.
• Coordinate validation, calibration, and preventive maintenance of manufacturing lab equipment.
• Develop and maintain Technical Operational Manuals, Standard Operating Procedures, and Batch Records.
• Assist in transferring and scaling new processes and technologies to the manufacturing plant.
• Review and approve batch records, process validation protocols, and other documentation.

Requirements

• Bachelor's degree in Science, Engineering, or related field with two years of biotech manufacturing experience; OR an Associate degree with four years of experience; OR a High School/GED with six years of experience.
• Two years of GMP experience.
• 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

• Competitive salary
• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities