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.
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).
Compensation: 128-147K base, 401K match (.50c per dollar), 3 weeks paid vacation, 1 week sick time, health, vision, dental, long term and short term disability.