Senior Manufacturing Systems Engineer DeltaV (Biotech Manufacturing)

Location: On-site in Holly Springs, North Carolina, United States; up to 10% domestic and international travel.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses.

What you will do

• Lead technical projects and automation initiatives for upstream, downstream, and solution preparation manufacturing operations.
• Design, build, commission, qualify, and integrate new equipment and systems for drug substance production.
• Develop process control automation solutions using the Emerson DeltaV distributed control system.
• Provide operational support, troubleshooting, root cause analysis, incident investigation, and change control for process and utility automation systems.
• Act as system owner for manufacturing automation processes and support new product and technology introductions.
• Develop specifications, SOPs, cGMP documentation, and operating standards while mentoring automation engineering staff.

Requirements

• High school diploma/GED plus 10 years of engineering experience, or an associate degree plus 8 years, bachelor's degree plus 4 years, master's degree plus 2 years, or a doctorate degree.
• Extensive experience with Emerson DeltaV, process control network design, virtual infrastructure, and system integration using OPC, Foundation Fieldbus, and Profibus.
• Experience designing, programming, installing, troubleshooting, and managing the lifecycle of manufacturing process controls and field instrumentation.
• Experience with GMP biopharmaceutical production equipment and upstream, downstream, or solution preparation unit operations.
• Knowledge of 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP standards, plus capital project lifecycle management and validation.
• Strong leadership, technical writing, communication, presentation, collaboration, and mentoring skills.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Comprehensive benefits and total rewards aligned with local industry standards.
• Support for professional growth, personal well-being, and career development.
• Work includes 24/7 manufacturing and facility operations support, including on-call responsibilities.