Senior Biotech Manufacturing Automation Engineer

ProQuality Network; United States; Híbrido; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

ProQuality Network is seeking a Sr. Associate Manufacturing Systems Engineer for a fully automated biotechnology manufacturing environment.

The role focuses on system optimization, upgrades, replacements, and modifications while ensuring maintenance complies with FDA regulations. This hands-on role requires strong troubleshooting, collaboration with maintenance and engineering teams, and support for a 24/7 operation across automation, utility, instrumentation, and maintenance systems.

Formación

• Bachelor’s degree in Engineering with at least 2 years of relevant experience; OR Associate’s degree with 6 years of engineering experience.
• Experience in FDA-regulated industries (preferred).
• Strong knowledge of PLC troubleshooting, particularly Rockwell systems.
• Experience troubleshooting Cognex Vision Systems.
• Knowledge of Systech Vision Systems troubleshooting and adjustments.
• Solid understanding of cGMP regulations.
• Knowledge of basic control systems hardware.

Responsabilidades

• Evaluate and ensure utility systems, process maintenance, instrumentation, calibration, electrical systems, and technical cleaning systems comply with corporate, industry, regulatory, and FDA standards.
• Support system/equipment optimization strategies, upgrades, replacements, and modifications.
• Ensure maintenance training programs, standard operating procedures, and operational standards are consistent and compliant.
• Coordinate and provide technical support to the maintenance team on engineering, regulatory, compliance, validation, calibration, quality, microbial/environmental, and electrical matters.
• Support maintenance activities during FDA and other regulatory inspections. Provide technical expertise in responses to regulatory agencies.
• Assist in investigations related to high purity water systems and environmental monitoring alert/action notifications.

Conocimientos

PLC troubleshooting

Cognex Vision Systems

Systech Vision Systems

cGMP compliance

FDA-regulated experience

Control systems hardware

Educación

Bachelor’s degree in Engineering

Associate’s degree with 6 years of engineering experience

Herramientas

Rockwell Automation

Descripción del empleo

ProQuality Network is seeking a Sr. Associate Manufacturing Systems Engineer for a fully automated biotechnology manufacturing environment.

The role focuses on system optimization, upgrades, replacements, and modifications while ensuring maintenance complies with FDA regulations. This hands-on role requires strong troubleshooting, collaboration with maintenance and engineering teams, and support for a 24/7 operation across automation, utility, instrumentation, and maintenance systems.