Automation Engineer

Job Responsibilities:

• Design, develop, implement, and support automation systems for pharmaceutical manufacturing processes and equipment
• Troubleshoot and resolve automation, control system, and process-related issues to minimize production downtime
• Support PLC, HMI, SCADA, and distributed control systems (DCS) used in GMP manufacturing environments
• Collaborate with Manufacturing, Engineering, Validation, Quality Assurance, and IT teams to support production operations and system integration
• Develop and maintain automation documentation including functional specifications, control narratives, wiring diagrams, and SOPs
• Support commissioning, qualification, and validation activities for automated systems and manufacturing equipment
• Configure, program, and optimize control systems to improve manufacturing efficiency, reliability, and product quality
• Monitor automation system performance and implement process improvements and corrective actions as needed
• Ensure automation systems comply with cGMP regulations, FDA guidelines, and data integrity requirements
• Participate in Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate automation and process risks
• Support implementation of new technologies, digital manufacturing solutions, and process automation initiatives
• Assist with change controls, deviation investigations, CAPA activities, and root cause analysis related to automation systems
• Partner with vendors and contractors to review equipment specifications, software requirements, and system functionality
• Maintain backup, cybersecurity, and disaster recovery procedures for manufacturing automation systems
• Support regulatory inspections, audits, and client requests by providing technical expertise and system documentation
• Drive continuous improvement initiatives focused on automation reliability, operational efficiency, and manufacturing performance

Qualifications:

• Bachelor’s degree in Electrical Engineering, Automation Engineering, Computer Engineering, Mechanical Engineering, or related technical field
• 3+ years of experience in pharmaceutical, biologics, medical device, or GMP-regulated manufacturing environments
• Experience with PLC programming, HMI development, SCADA systems, and distributed control systems (DCS)
• Knowledge of automation platforms such as Rockwell Automation, Siemens, DeltaV, Ignition, or similar systems preferred
• Strong understanding of cGMP regulations, FDA requirements, and pharmaceutical manufacturing operations
• Experience supporting automated manufacturing equipment, process controls, and instrumentation systems
• Familiarity with process validation, equipment qualification, computerized system validation (CSV), and data integrity requirements
• Understanding of networking, industrial communication protocols, and system integration concepts preferred
• Experience with troubleshooting electrical, instrumentation, and control system issues
• Knowledge of risk management tools such as FMEA preferred
• Lean Six Sigma certification or continuous improvement experience preferred
• Strong analytical, troubleshooting, and problem-solving skills
• Excellent communication, technical writing, and cross-functional collaboration abilities
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• Proficiency with Microsoft Office, automation software platforms, and technical documentation systems preferred