Technical & Engineering Consulting LLC is seeking an experienced Automation Engineer to support an Alarm Rationalization Program within a pharmaceutical manufacturing environment.
The ideal candidate will have hands-on experience with automation and control systems, alarm management, data analysis, change controls, and validation activities within GMP-regulated operations. This role will work cross-functionally with Engineering, Operations, Quality, EHS, Technical Services, and Automation teams to identify, evaluate, rationalize, and implement alarm improvements across manufacturing and utility areas.
Key Responsibilities
- Serve as a Subject Matter Expert (SME) for alarm configuration within Rockwell Automation PLC/HMI and/or DeltaV systems
- Extract, consolidate, and analyze alarm and event data using Logmate or equivalent tools
- Identify nuisance alarms, bad actors, alarm floods, and opportunities for alarm optimization
- Lead and facilitate alarm rationalization activities, including evaluation of:
- Alarm setpoints
- Priorities
- Causes and consequences
- Corrective actions
- Develop and maintain alarm rationalization documentation and the master alarm database
- Initiate, prepare, and manage Change Controls through generation, review, approval, and implementation
- Configure and/or validate approved alarm changes within automation systems
- Support compliance with data integrity and GMP requirements throughout the change lifecycle
- Coordinate instrumentation, setpoint, and control-module changes with Process and Engineering teams
- Lead configuration, testing, and validation activities associated with implemented alarm changes
- Track and report program KPIs and alarm-management performance
- Provide troubleshooting support for PLC/HMI and DeltaV alarm-related issues
- Author and/or review SOPs, drawings, schematics, work orders, user requirements, and functional specifications
- Support continuous improvement and periodic re-rationalization activities
Qualifications
- Bachelor's degree in Electrical, Chemical, Computer, Mechanical, Industrial Engineering, or related engineering discipline
- Experience in automation, controls, or related engineering roles
- Experience and knowledge of DeltaV, Rockwell Automation PLC/HMI, and instrumentation is highly desirable
- Experience in GMP-regulated manufacturing environments
- Computer Systems Validation experience
- Strong data analysis skills, including Excel and alarm management/reporting tools
- Experience managing multiple priorities and working with cross-functional teams
- Strong analytical, problem-solving, communication, and collaboration skills
- Availability to provide support to a 24/7 manufacturing operation, as required
Preferred
- Previous experience with Alarm Management or Alarm Rationalization
- Knowledge of ISA-18.2 and/or EEMUA 191 principles
- Experience with Veeva Vault or equivalent electronic quality management systems
- Experience managing Change Controls
- Experience with Logmate or similar alarm management/reporting platforms
- Hands-on experience with automation configuration, testing, and validation
Work Environment
- Full-time, on-site pharmaceutical manufacturing environment in Carolina, Puerto Rico
- Hands-on automation and field-support role
- Cross-functional interaction with Automation, Process Engineering, Operations, Quality, EHS, and Technical Services
- Work may involve support across manufacturing, utilities, and process areas
