Pharmaceutical Automation Engineer- Mesa,AZ

Design and implement automation control systems for BMS, EMS, and SCADA to monitor critical parameters such as temperature, humidity, differential pressure, HVAC performance, and cleanroom controls.

Configure and integrate Human-Machine Interfaces (HMIs) for operator control and monitoring of pharmaceutical processes.

Develop and maintain functional specifications, logic diagrams, wiring schematics, and network architecture for automation systems.

Collaborate with IT teams to define requirements for low-voltage cabling, IP address allocation, network security, and VPN access to support remote login and system integration for facilities as well as cleanroom equipment.

Coordinate with cybersecurity stakeholders and risk management to ensure compliance with data integrity and system access standards (e.g., 21 CFR Part 11, GAMP 5).

Support installation, commissioning, and qualification of automation hardware and software systems.

Troubleshoot hardware and communication issues between PLCs, HMIs, sensors, and enterprise systems.

Maintain and update automation system backups, patch management logs, and system audit trails.

Ensure automation systems meet GxP, FDA, cGMP, and 21 CFR Part 11 compliance standards.

Prepare and maintain validation documentation (e.g., IQ/OQ protocols), URS, FRS, and SOPs related to automation systems.

Support internal and regulatory audits by providing technical documentation and system access logs.

Interface with validation, QA, and facilities engineering teams to support ongoing system monitoring, alarms, alerts, and environmental excursion response.

Work with vendors and contractors during new system implementation or upgrades.

-Bachelor’s degree in Electrical Engineering, Automation, Computer Engineering, or a related technical field.

-3–5+ years of experience working with automation systems in regulated environments (pharmaceutical, biotech, medical device, or cleanroom facilities).

-Hands-on experience with BMS, EMS, SCADA platforms (like Ignition, Wonderware, Rockwell FactoryTalk but not limited to), and HMI development (e.g., Siemens, Allen-Bradley, Schneider Electric).

-Working knowledge of low-voltage infrastructure, remote access setup (VPNs, firewalls), and industrial networking (Ethernet/IP, Modbus, OPC UA).

-Familiarity with PLC programming, alarm management, data historian integration, and audit trail review.

-Understanding of regulatory compliance requirements such as 21 CFR Part 11, cGMP, and GAMP 5.

-Strong analytical, problem-solving, and communication skills with the ability to work independently and across cross-functional teams.

-Strong skills in process mapping, data analysis, root cause analysis, and the use of statistical tools for performance improvement. Experience with AutoCAD or other facility layout and engineering design tools.

-Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.

-Willingness to travel as required for vendor FATs and document punch list items for correction.

-Hands-on experience supporting 503A and/or 503B compounding operations, with working knowledge of pharmacy regulatory standards.

-Strong analytical and problem-solving skills, with the ability to troubleshoot complex technical issues.

-Excellent written and verbal communication skills and the ability to work effectively across cross-functional teams.