Automation Engineer

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary
The Automation Engineer is responsible for supporting manufacturing operations through the design, implementation, validation, and lifecycle management of automation systems in a GMP-regulated biopharmaceutical environment.
This role ensures systems remain in a state of control, compliance, and reliability, while supporting production, capital projects, and continuous improvement initiatives.
Key Responsibilities
*Automation Systems & Engineering*

• Develop, configure, and maintain automation systems including:
• DCS (DeltaV)
• PLCs (Rockwell / Siemens)
• SCADA / HMI systems
• BMS systems
• Support system integration across manufacturing and utility platforms
• Maintain system documentation and lifecycle management

*Validation & Qualification (Automation Systems)*

• Develop and execute validation protocols (IQ/OQ/PQ) and/or CSV deliverables for automated systems
• Generate and review:
• Validation Plans
• User Requirements Specifications (URS)
• Functional/Design Specifications (FRS/DS)
• Test protocols and reports
• Ensure systems meet GMP and data integrity requirements
• Support maintaining systems in a validated state

*Operational Support & Troubleshooting*

• Provide day-to-day automation support to manufacturing operations
• Lead and support troubleshooting and Root Cause Analysis (RCA)
• Ensure system uptime, reliability, and performance
• Support on-call or off-hours activities as needed

*Quality Systems & Compliance*

• Support and manage Change Controls related to automation systems
• Participate in and support:
• Deviations
• CAPAs
• Investigations
• Assess impact of system changes on validated state and product quality
• Ensure compliance with:
• GMP regulations
• Data Integrity standards
• Internal procedures

*Project & Capital Support*

• Support automation scope for capital projects, upgrades, and expansions
• Participate in:
• Commissioning and startup activities
• Equipment and system qualification
• New Product Introduction (NPI) and tech transfer
• Collaborate with cross-functional teams to ensure project success

*Continuous Improvement*

• Identify and implement improvements in:
• System performance
• Process efficiency
• Automation reliability
• Support digital transformation and automation optimization initiatives

*Data Integrity & System Lifecycle*

• Ensure automation systems comply with data integrity and cybersecurity standards
• Maintain audit trails, backups, and system security
• Support lifecycle management, upgrades, and patching

Basic Qualifications

• Bachelor’s Degree in Engineering (Electrical, Computer, Chemical, Mechanical, or related field)

• 7+ years of experience in automation engineering

Preferred Qualifications

• Experience in biopharmaceutical or GMP-regulated environments
• Hands-on experience with:
• DeltaV DCS
• PLC/HMI/SCADA systems
• BMS systems
• Experience with:
• Validation (IQ/OQ/PQ, CSV)
• Protocol development and execution
• Change control systems
• Knowledge of manufacturing processes (upstream/downstream preferred)

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.