Senior Automation Engineer

Description:

The Automation Engineer designs, implements, qualifies, and supports automation and control systems for sterile pharmaceutical manufacturing. The role ensures reliable, compliant operation of PLCs, VFDs, HMI/SCADA, DCS, BMS/EMS, instrumentation, and industrial network systems. Working with Manufacturing, Quality, Validation, IT/OT, vendors, and integrators, the engineer supports capital projects, technology transfer, commissioning, qualification, troubleshooting, lifecycle management, and continuous improvement for sterile processing and packaging operations.

Essential Functions:

• Develops and maintains automation and controls solutions for sterile manufacturing equipment, utilities, and facilities. Prepares or reviews user requirements, functional and design specifications, control narratives, I/O lists, alarm strategies, network architecture, and configuration documentation. Programs, configures, tests, and supports PLC, VFD Programming, HMI/SCADA, distributed control system, BMS/EMS, historian, instrumentation, drives, motion-control, and related systems while maintaining approved configuration baselines and lifecycle plans.

• Leads or executes assigned automation workstreams for new equipment, facility upgrades, technology transfer, and process improvements. Coordinates system integrators, equipment vendors, contractors, Manufacturing, Quality, Validation, and IT/OT. Supports design reviews, factory and site acceptance testing (FAT/SAT), commissioning, startup, automation qualification, and IQ/OQ/PQ activities; verifies traceability to approved requirements and ensures timely turnover of complete technical documentation.

• Provides day-to-day technical support for automated sterile manufacturing and packaging systems. Diagnoses control, instrumentation, communication, sequence, interlock, alarm, and equipment-performance issues; analyzes system and historian data; performs root-cause analysis; and implements sustainable corrective actions. Supports planned shutdowns, maintenance, calibration, production changes, and after-hours response when required to protect product quality, personnel safety, and reliable operations.

• Compliance, Data Integrity, and Quality Systems: Ensures automation changes and computerized system records comply with cGMP, good documentation practices, applicable electronic-record requirements, data-integrity principles, cybersecurity controls, and approved site procedures. Initiates or supports change controls, impact and risk assessments, deviations, investigations, CAPA, access reviews, audit-trail reviews, backup and recovery verification, periodic reviews, and system retirement activities.

• Creates and maintains SOPs, work instructions, system inventories, drawings, code and configuration records, preventive-maintenance requirements, and training materials. Trains operations and maintenance personnel on automation-system operation and troubleshooting. Identifies and implements improvements that enhance reliability, compliance, process capability, cycle time, yield, alarm effectiveness, and obsolescence management.

Additional Responsibilities:

• Maintains automation inventories, source-code and configuration backups, recovery procedures, network diagrams, licenses, spare-parts information, and obsolescence plans in an inspection-ready state. Reviews P&IDs, control and electrical drawings, loop diagrams, cause-and-effect matrices, specifications, vendor documents, calibration records, and maintenance records for automation impact. Coordinates controlled implementation windows and confirms that approved changes, trained personnel, calibrated instruments, backups, and rollback plans are available before execution.