Sr. Manufacturing Systems Engineer (Automation Engineer)

Location: Juncos, Puerto Rico, United States; on-site production environment

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Serve as a subject matter expert in manufacturing systems, automation, and digital manufacturing technologies.
• Lead implementation and support for MES, SCADA, PLC integration, and other manufacturing IT Tier systems.
• Design, configure, troubleshoot, commission, qualify, test, and maintain automation systems across their lifecycle.
• Develop system requirements, design specifications, test plans, SOPs, engineering standards, and lifecycle documentation.
• Support validation, change control, deviations, CAPAs, audits, inspections, and data-integrity activities.
• Analyze system performance and lead continuous-improvement initiatives focused on safety, reliability, throughput, efficiency, and sustainability.

Requirements

• Doctorate degree in Engineering, or a master’s degree in Engineering with 2 years of Manufacturing Systems/Automation experience, or a bachelor’s degree in Engineering with 4 years of such experience.
• Experience supporting automation systems in a regulated manufacturing environment, preferably biopharmaceutical manufacturing.
• Three or more years of combined experience with AVEVA Wonderware InTouch and Rockwell Automation PLC/SCADA platforms.
• Experience with process-control networks, virtual-server infrastructure, industrial system integration, field instrumentation, control valves, transmitters, and control-loop troubleshooting.
• Knowledge of GMP/GxP, 21 CFR Part 11, GAMP 5, ASTM E2500, ISA-88, ISA-95, GDP, computerized-system validation, data integrity, and cybersecurity requirements.
• Ability to support manufacturing operations and capital projects in an on-site production environment and provide automation leadership to site teams.

Nice to have

• Experience with OPC, Profibus, DeviceNet, Ethernet/IP, OEM skid interfaces, and electronic batch reporting.
• Knowledge of upstream and downstream bioprocess operations, including media preparation, bioreactors, chromatography, filtration, and UF/DF.
• Experience leading complex capital projects, automation lifecycle initiatives, investigations, change controls, deviations, CAPAs, and corrective actions.

Culture & Benefits

• Collaborative, innovative, and science-based work environment focused on serving patients.
• Health, dental, vision, life, and disability insurance for employees and eligible dependents.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Annual bonus program, paid time off, annual site shutdown, and career development opportunities.
• Flexible work models may be available where applicable; this role is associated with an on-site production environment.