Principal Manufacturing Systems Engineer (Upstream/Downstream Process Automation)

Location: Holly Springs, North Carolina, United States; onsite role with 24/7 onsite/on-call support and up to 10% domestic or international travel

Salary: $140,334.15–$189,863.85 annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines, including drug substance produced at the FleX Batch facility.

What you will do

• Serve as the automation subject matter expert for upstream and downstream bioprocessing systems.
• Support site design, construction, commissioning, qualification, start-up, and operational readiness activities.
• Develop process-control solutions primarily using Emerson DeltaV Distributed Control System.
• Own and support plant automation systems, including troubleshooting, configuration changes, qualification runs, and 24/7 operational support.
• Lead improvements in safety, reliability, efficiency, sustainability, cycle times, and manufacturing yields.
• Represent automation during audits, regulatory inspections, global forums, and cross-functional technical decisions.

Requirements

• Doctorate degree and 2 years of engineering experience, or a master’s degree and 4 years, bachelor’s degree and 6 years, associate’s degree and 10 years, or high school diploma/GED and 12 years.
• At least 2 years of managerial experience or leadership experience directing people, teams, projects, programs, or resources.
• Experience with Emerson DeltaV, process control network design, virtual infrastructure, OPC, Foundation Fieldbus, and Profibus.
• Knowledge of biopharmaceutical manufacturing processes, including upstream processing, downstream purification, chromatography, viral filtration, UFDF, and CIP/SIP skids.
• Experience with GMP-regulated environments, 21 CFR Part 11, GAMP, GDP, S88, S95, validation, change control, deviations, and regulatory inspections.
• Willingness to work a flexible schedule, including occasional after-hours engineering coverage for 24/7 operations.

Nice to have

• Degree in electrical engineering, computer science, chemical engineering, or biotech engineering.
• Experience with IO-Link, Process Analytical Technology, OEM automation software, and field instrumentation.
• Experience with tech transfer, process design, and commissioning and qualification.
• Strong mentoring, technical writing, communication, presentation, and cross-functional leadership skills.

Culture & Benefits

• Work alongside engineering, manufacturing, quality, maintenance, process development, and network teams.
• Contribute to a new drug-substance manufacturing facility combining disposable technologies, stainless-steel equipment, and Industry 4.0 capabilities.
• Support sustainability initiatives focused on reducing carbon emissions and waste.
• Participate in technical mentoring and development of site automation capabilities.