Senior Automation Controls Engineer

• Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems.
• Provide support for the engineering and design of automated systems.
• Understand and read complex ladder logic.
• Understand PLC/ PC based controllers and functionality.
• Troubleshoot low voltage control wiring.
• Working knowledge of vision inspection systems.
• Troubleshoot filling and packaging equipment.
• Define requirements for vendor design documentation.
• Generate user requirement specifications for control systems.
• Review vendor automation design documentation (FRS, DDS, requirements traceability matrix, code, and logic).
• Working knowledge of vision inspection systems and related quality processes in a GMP environment.
• Review qualification protocols of automated systems.
• Support the execution of the qualification of automated control systems.
• Proficient in reading and interpreting electrical schematics for troubleshooting and repair.
• Managing projects / processes, working independently with limited supervision.
• Reviewing the work of lower level professionals or contractors.
• Prepare risk assessments for automated systems.
• Prepare Change Controls associated with changes to control systems.
• Able to perform complex assessments for computer systems against current industry compliance requirements.
• Be flexible to work on off-shifts as needed to support a 3 shifts operation.

Experience

Required

• A bachelor's degree in engineering (e.g., electrical, mechanical, or control systems engineering) or a related field with 5+ years of experience in automation and controls in a pharmaceutical environment is typically required. Knowledge of PLC logic, vision systems, control loops, input/output control sequences and PC based systems. Basic understanding of SQL servers, databases, networking, and Excel automation. Familiarity with industry practices and guidelines (FDA, ISO, EU, ICH).

Equal Opportunity Employer
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