Senior Manufacturing Systems Engineer (Automation, DeltaV)

Location: Holly Springs, North Carolina, United States. Swing shift from 3:00 PM to 11:00 PM, Monday through Friday, with 24/7 onsite/on-call operational support.

Company

hirify.global is a global biotechnology company developing, manufacturing, and delivering medicines, including products made at its advanced FleXbatch drug substance manufacturing facility.

What you will do

• Provide technical leadership for automation engineering supporting GMP drug substance plant operations.
• Develop and maintain Emerson DeltaV distributed control system applications and process-control strategies.
• Translate process requirements into digital automation solutions and integrate multiple automation platforms.
• Support commissioning, qualification, automation installation verification, automation checkout, and computerized systems validation.
• Lead change controls, CAPAs, deviations, root-cause investigations, troubleshooting, preventive and corrective maintenance, and system administration.
• Support capital projects, new product and technology introductions, process improvements, and day-to-day plant automation operations.

Requirements

• High school diploma/GED with 10 years of engineering experience; associate degree with 8 years; bachelor's degree with 4 years; master's degree with 2 years; or doctorate degree.
• Experience designing, programming, installing, troubleshooting, and managing the lifecycle of manufacturing automation and field-instrumentation systems.
• Experience with Emerson DeltaV DCS, process-control network design and segregation, virtual infrastructure, and system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet.
• Knowledge of GMP/GAMP requirements and regulated documentation, including 21 CFR Part 11, ASTM 2500, S88, and S95.
• Experience with capital project lifecycle management, process-control strategy development, qualification, and validation documentation.
• Strong technical writing, communication, presentation, leadership, mentoring, and collaboration skills.

Nice to have

• Degree in electrical engineering, computer science, chemical engineering, biotech engineering, or a related field.
• Experience with DeltaV Live.
• Direct experience with GMP biopharmaceutical manufacturing systems such as bioreactors, chromatography, filtration, clean utilities, CIP/SIP, and drug substance filling.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time off plans and biannual company-wide shutdowns.
• Career development opportunities and flexible work models where applicable.