Automation Engineer

Job Title: Automation EngineerJob Description

The Automation Engineer provides first and second-level support for building automation systems (BMS), process control systems, utilities, and HVAC systems in a regulated pharmaceutical manufacturing environment. This role focuses on maintenance, troubleshooting, emergency response, and ensuring reliable operation of facility and utility infrastructure. The Automation Engineer also defines service, equipment, and maintenance specifications, including associated SAP procedures, and plays a key role in continuous improvement and compliance with cGMP requirements.

Responsibilities

• Carry out engineering activities on automation systems and lead internal projects related to investments, system updates, planned exceptions, and change controls for repairs or interventions.
• Connect to PLCs to perform programming analysis, diagnosis, and troubleshooting in support of reliable system operation.
• Manage the lifecycle, maintenance, and compliance requirements of complex control systems that support pharmaceutical production.
• Develop recommendations and technical solutions to eliminate system weak points and drive continuous improvement of automation and utility infrastructure.
• Ensure documentation is created and maintained in accordance with cGMP standards and regulatory expectations.
• Ensure the technical availability and reliability of all building automation systems and process control systems, including maintaining availability of critical replacement parts.
• Establish user requirement specifications for new equipment and define service and maintenance specifications, including all relevant SAP procedures.
• Provide technical supervision, coordination, and oversight of external contractors and service providers working on automation, utilities, and HVAC systems.
• Inspect equipment-related documentation, such as user requirement specifications and operating instructions, and revise standard operating procedures (SOPs) and quality control (QC) forms as needed.
• Monitor the technical performance of existing systems, equipment, machines, devices, and utilities to identify issues and improvement opportunities.
• Organize and supervise equipment installation, startup, and approval/release activities to ensure systems are properly commissioned and ready for production use.
• Participate in a rotating on-call duty schedule to respond to critical system or equipment failures and provide timely technical support.
• Perform troubleshooting and weakness analysis, including incident management, root cause analysis, and system recovery activities.
• Present engineering documentation during inspections and audits and clearly explain system design, operation, and compliance measures.
• Support external and internal audits by providing facility tours, presenting documentation and trending data, and defending procedures and technical dec...

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