Automation Lead (Pharmaceutical Manufacturing)

Location: Middletown, Delaware, United States; on-site

Company

hirify.global operates in pharmaceutical and biotechnology research, development, and manufacturing services.

What you will do

• Serve as the primary automation subject matter expert for sterile manufacturing equipment, Environmental Monitoring Systems, and GMP utility systems.
• Support the full automation lifecycle, including architecture and design reviews, vendor coordination, FAT, SAT, installation, commissioning, qualification, start-up, operation, and lifecycle management.
• Lead troubleshooting and root cause analysis for automation failures, control-system issues, communication problems, alarms, and recurring equipment-performance issues.
• Drive system reliability, performance optimization, backup and recovery strategies, alarm rationalization, cybersecurity, upgrades, and continuous improvement.
• Support technology transfer, scale-up, automation recipes, control strategies, system interfaces, and electronic data requirements.
• Collaborate with Manufacturing, Quality, Validation, IT/OT, Engineering, Supply Chain, Program Management, vendors, and system integrators.

Requirements

• Bachelor’s or Master’s degree in Automation, Electrical, Control, Computer Engineering, or a related technical discipline.
• At least 5 years of automation or controls engineering experience in pharmaceutical, biotechnology, or another highly regulated manufacturing industry.
• Hands-on experience with PLC, HMI, SCADA, DCS, Historian systems, industrial communication networks, and control-system troubleshooting.
• Experience with automation design, FAT, SAT, commissioning, qualification, start-up, and lifecycle management of GMP computerized systems.
• Strong knowledge of cGMP, FDA 21 CFR Part 11, EU GMP Annex 11, GAMP principles, data integrity, cybersecurity, and electronic records management.
• Must work on-site in Middletown, Delaware.

Nice to have

• Experience with pharmaceutical manufacturing equipment and GMP utilities such as WFI, clean steam, compressed air, and nitrogen.
• Experience supporting the start-up or expansion of pharmaceutical or biotechnology manufacturing facilities.

Culture & Benefits

• Individual contributor role with no direct reports.
• Technical guidance and coaching responsibilities for automation engineers, technicians, and other technical staff.
• Collaboration across global engineering, manufacturing, quality, validation, IT/OT, and external vendor functions.
• Work focused on accountability, continuous improvement, technical excellence, and proactive problem solving.