What are the responsibilities and job description for the Automation Engineer position at GxP Associates?
Position Summary
We are seeking a driven Automation Engineer with 0–3 years of experience to support automation systems within a cGMP-regulated pharmaceutical/biotech manufacturing environment in New Jersey. This role provides hands-on exposure to PLC/SCADA systems, process automation, and validation (CSV/CSA), making it an excellent opportunity for early-career professionals to build expertise in industrial automation and regulatory compliance.
Key Responsibilities
- Support design, development, and maintenance of automation systems (PLC, HMI, SCADA) for manufacturing processes.
- Assist in programming, troubleshooting, and optimization of PLC systems (e.g., Allen-Bradley, Siemens).
- Participate in commissioning, startup, and qualification of automated equipment and control systems.
- Support Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, including protocol execution (IQ/OQ/PQ).
- Monitor and maintain SCADA systems and data historians to ensure system reliability and data integrity.
- Collaborate with Engineering, IT, Manufacturing, and Quality teams to resolve automation issues and implement improvements.
- Assist in change control, deviation investigations, and CAPA activities related to automation systems.
- Ensure compliance with cGMP, FDA regulations, and data integrity (ALCOA ) principles.
- Support preventive maintenance, system upgrades, and lifecycle management of automation systems.
- Maintain proper technical documentation, SOPs, and system configurations.
Basic Qualifications
- Bachelor’s degree in Electrical, Electronics, Instrumentation, Automation, or related Engineering discipline.
- 0–3 years of experience in automation, controls engineering, or related field (internships/projects acceptable).
- Basic knowledge of PLC programming and control systems.
- Understanding of SCADA/HMI systems and industrial automation concepts.
- Familiarity with cGMP and regulated environments is a plus.
- Strong analytical and troubleshooting skills.
- Good communication and teamwork abilities.
Preferred Qualifications
- Exposure to pharmaceutical, biotech, or medical device manufacturing environments.
- Hands-on experience or familiarity with Allen-Bradley (Rockwell), Siemens, DeltaV, or Emerson systems.
- Basic understanding of Computer System Validation (CSV) or CSA frameworks.
- Knowledge of industrial communication protocols (Modbus, Ethernet/IP, OPC).
- Familiarity with data historians (e.g., OSIsoft PI).
- Exposure to MES systems or batch processing (ISA-88/ISA-95) is a plus.