Automation Engineer

About Us

American Injectables is a fast-growing Contract Development and Manufacturing Organization (CDMO) specializing in injectable pharmaceuticals. We are expanding our capabilities and investing in automation to enhance our turnkey solutions. As part of this expansion, we are seeking an experienced Automation Engineer with deep expertise in PLC programming, SCADA systems, and pharmaceutical manufacturing equipment or similar.

Job Summary

As an Automation Engineer, you will be responsible for the design, programming, troubleshooting, and optimization of automated systems across our facility. You will work on a variety of pharmaceutical processing equipment, including water systems, parts washers, autoclaves, filling lines, and other bespoke systems that involve complex control routines including motion control. Your role will be critical in ensuring the reliability, compliance, and efficiency of our automated manufacturing processes.

Key Responsibilities

PLC Programming & Troubleshooting:

• Develop, modify, and optimize PLC programs for Allen-Bradley (Rockwell) and Siemens platforms.
• Perform hands-on troubleshooting and debugging of control systems, identifying root causes and implementing long-term solutions.
• Integrate automation with HMI and SCADA systems to ensure smooth process control and data acquisition.
• Ensure compliance with cGMP, GAMP5, FDA regulations, and 21 CFR Part 11 for automation systems.

SCADA & Industrial Control Systems:

• Configure and manage SCADA systems such as Ignition and/or Wonderware for real-time process monitoring and control.
• Develop data acquisition and reporting tools to improve process visibility and compliance tracking.
• Work with cross-functional teams to ensure seamless integration of SCADA systems with MES (Manufacturing Execution Systems) and data historians.

Pharmaceutical Equipment Automation & Integration:

• Provide automation support for purified water (WFI), clean steam, HVAC, isolators, filling lines, and other critical systems and utilities.
• Optimize data reporting of sterilization (autoclaves, depyrogenation tunnels), washing systems, filling and packaging lines.
• Implement and maintain motion control systems (servo drives, pneumatics, robotics) for high-precision operations.

System Validation & Compliance:

• Author and execute IQ, OQ, and PQ validation protocols for automation systems.
• Ensure compliance with GAMP 5, 21 CFR Part 11, and data integrity standards.
• Support FDA inspections and customer audits related to automation and data integrity.

Collaboration & Continuous Improvement:

• Work closely with process engineers, maintenance teams, and quality assurance to optimize automation processes.
• Participate in the design, FAT, SAT, commissioning, and qualification of new automation projects.
• Identify and implement improvements for OEE (Overall Equipment Effectiveness), cycle time reduction, and energy efficiency.

Qualifications & Skills

Must-Have:

• 5 years of hands-on PLC programming experience with Allen-Bradley (Rockwell) and Siemens.
• Strong understanding of SCADA systems (Ignition, Wonderware, or equivalent).
• Experience with pharmaceutical automation, including water systems, sterilization, and aseptic processing equipment.
• Deep understanding of PLC programming methods, motion control, pneumatics, servos, and control devices.
• Knowledge of cGMP, 21 CFR Part 11, and GAMP 5 automation compliance.
• Ability to read and interpret P&IDs, electrical schematics, and control logic diagrams.

Preferred:

• Proficiency in Python for scripting, automation, and data analysis.
• Experience integrating PLC/SCADA with MES, ERP, and data historians.
• Knowledge of industrial networking (Ethernet/IP, Profibus, Modbus, OPC-UA).
• Experience in root cause analysis (RCA) and failure mode analysis (FMEA).

Why Join Us?

• Be part of a rapidly expanding pharmaceutical CDMO with state-of-the-art automation projects.
• Work on cutting-edge sterile manufacturing technologies.
• Competitive salary and benefits with opportunities for career growth and leadership roles.
• A collaborative team environment where your expertise will directly impact drug manufacturing and patient safety.