Senior OT Engineer, GMP Systems & Lab Automation

BioTalent; Tustin (CA); Vor Ort; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

BioTalent seeks a Senior Engineer, Operational Technology to support manufacturing, laboratory, and enterprise systems within a regulated GMP environment. You will serve as a technical expert for specialized manufacturing, process development, and quality control systems to ensure platforms operate reliably, securely, and in compliance with applicable policies and regulatory expectations.

The role requires documentation, design and testing activities, change management support, and close

Qualifikationen

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or related discipline.
• 5+ years of experience in GMP environments.
• Experience with manufacturing, laboratory, or automation platforms.
• Knowledge of 21 CFR Part 11, GAMP 5, data integrity, and GMP regulations.

Aufgaben

• Lead and maintain system administration documentation for laboratory instruments, enterprise systems, manufacturing equipment, and regulated applications to support reliable, compliant operations.
• Develop, review, and update design specifications, work instructions, technical procedures, and support documentation for GMP equipment, systems, and processes.
• Support the development, modification, and execution of test methods and system testing activities for laboratory and manufacturing equipment.
• Provide technical and documentation support for change management, deviation investigations, corrective actions, system upgrades, and lifecycle management activities.
• Perform equipment and application testing and train technical staff on developed, upgraded, or acquired software and hardware.
• Lead complex troubleshooting, coordinate vendor engagement, and drive problem resolution for regulated systems and equipment.

Kenntnisse

GMP compliance

Regulatory awareness

Ausbildung

Bachelor's degree in Life Sciences/Engineering/CS

Jobbeschreibung

BioTalent seeks a Senior Engineer, Operational Technology to support manufacturing, laboratory, and enterprise systems within a regulated GMP environment. You will serve as a technical expert for specialized manufacturing, process development, and quality control systems to ensure platforms operate reliably, securely, and in compliance with applicable policies and regulatory expectations.

The role requires documentation, design and testing activities, change management support, and close