Senior Engineer, Operational Technology

BioTalent; Tustin (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP compliance

Regulatory awareness

Education

Bachelor's degree in Life Sciences/Engineering/CS

Job description

We are partnering with a leading biopharmaceutical manufacturing organization seeking a Senior Engineer, Operational Technology to support manufacturing, laboratory, and enterprise systems in a regulated GMP environment. This role serves as a technical expert for specialized manufacturing, process development, and quality control systems, ensuring platforms operate reliably, securely, and in alignment with applicable policies, procedures, and regulatory expectations.

Key Responsibilities

• 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.

Qualifications & Requirements

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or a related discipline; relevant experience may substitute for the degree requirement on a year-for-year basis.
• 5+ years of experience supporting regulated systems in a GMP environment.
• Experience with manufacturing, laboratory, or automation platforms.
• Knowledge of 21 CFR Part 11, GAMP 5, data integrity, and GMP regulations.

This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future.