Senior Automation Controls Engineer

LTS Nasal and Sterile Drug Products; Lakewood Township (NJ); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

LTS Nasal and Sterile Drug Products in Lakewood, NJ seeks an Automation Engineer to support GMP automation projects and system qualification activities. You will read ladder logic, troubleshoot PLC/PC controllers, and review vendor design documentation within a cGMP framework.

The role requires knowledge of vision inspection systems, change controls, and risk assessments, with the ability to work closely with QA and engineering teams across multiple shifts.

Formación

• Understand 21 CFR Part 11, cGMP and other regulatory guidance for automated systems.
• Reading and interpreting complex ladder logic.
• Experience with PLC/PC based controllers.
• Working knowledge of vision inspection systems in GMP environments.
• Review vendor automation design documentation (FRS, DDS, traceability).

Responsabilidades

• 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.
• Working knowledge of vision inspection systems.
• Troubleshoot filling and packaging equipment.
• 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.

Conocimientos

Regulatory compliance 21 CFR Part 11 c

Automation design

Ladder logic reading

PLC/PC controllers

Vision inspection systems

Troubleshooting GMP equipment

Requirements specifications

Documentation review

Risk assessments

Change controls

Project management

Independent work

Herramientas

Electrical schematics

Descripción del empleo

• 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.
• Working knowledge of vision inspection systems.
• Troubleshoot filling and packaging equipment.
• 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.