Senior Automation Controls Engineer

Renaissance Lakewood LLC; Lakewood Township (NJ); On-site; USD 128,000 - 146,000; Full time

Job summary

Renaissance Lakewood LLC seeks an experienced automation engineer to support design and engineering of pharmaceutical automated systems. You will understand ladder logic, PLC/PC-based controllers, and vision systems to ensure compliant operation within a GMP environment.

The role requires 5+ years in automation in pharma and familiarity with FDA/ISO guidelines, with flexibility to cover a three-shift operation as needed.

Qualifications

• Bachelor's degree in engineering and 5+ years in automation and controls in pharma.
• Knowledge of PLC logic, vision systems, control loops, and PC-based systems.
• Basic understanding of SQL servers, databases, networking, and Excel automation.
• Familiarity with FDA, ISO, EU, ICH guidelines.

Responsibilities

• Understand and apply 21 CFR Part 11 and cGMP to automated systems.
• Provide support for engineering and design of automation.
• Understand and read complex ladder logic.
• Review vendor automation design documentation (FRS, DDS, etc.).
• Prepare risk assessments and Change Controls for automated systems.
• Be flexible to work off-shifts to support a 3 shifts operation.

Skills

PLC logic

Vision systems

Electrical schematics

Project management

GMP compliance

Excel automation

Education

Bachelor's degree in engineering

Tools

SQL

Databases

Networking

Job description

• Pay or shift range: $128,100 USD to $146,400 USD
  The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

Description

• 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.

Qualifications

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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