Principal Manufacturing Systems Engineer (Upstream/Downstream Process Automation)

Location: Holly Springs, North Carolina; corporate headquarters listed in Thousand Oaks, California, United States. The role includes 24x7 onsite/on-call support, occasional after-hours coverage, and up to 10% domestic and international travel.

Company

hirify.global is a biotechnology company developing and manufacturing medicines, including drug-substance products at the hirify.globalFleXBatch facility.

What you will do

• Represent site automation requirements during design, construction, commissioning, qualification, and operational-readiness activities.
• Develop and implement process-control automation solutions, primarily using Emerson DeltaV DCS, for upstream and downstream bioprocessing.
• Lead Automation Installation Verification and Automation Check Out activities while ensuring GMP compliance and project delivery.
• Own plant automation systems and provide day-to-day troubleshooting, technical support, and reliability leadership for 24x7 operations.
• Implement system configuration changes, support engineering and process-qualification runs, and lead continuous-improvement initiatives focused on safety, efficiency, yields, reliability, and sustainability.
• Mentor engineers, influence site and network automation standards, collaborate with manufacturing and quality teams, and represent automation during audits and regulatory inspections.

Requirements

• Doctorate with 2 years of engineering experience, master's degree with 4 years, bachelor's degree with 6 years, associate's degree with 10 years, or high school diploma/GED with 12 years.
• At least 2 years of managerial experience or experience leading teams, projects, programs, or resource allocation.
• Extensive experience with Emerson DeltaV, process control network design and segregation, virtual infrastructure, and system integration using OPC, Foundation Fieldbus, and Profibus.
• Experience with regulated biopharmaceutical manufacturing, including GMP, 21 CFR Part 11, GAMP, S88, S95, validation, change control, deviations, and corrective and preventive actions.
• Knowledge of upstream and downstream processes, including seed trains, production bioreactors, harvest, chromatography, viral filtration, UFDF, and CIP/SIP skids.
• Flexibility to support 24x7 operations, including occasional after-hours engineering coverage.

Nice to have

• Degree in electrical engineering, computer science, chemical engineering, or biotech engineering.
• Experience with IO-Link, process analytical technology, OEM automation software, field instrumentation, tech transfer, process design, and commissioning and qualification.
• Experience interacting with regulatory agencies and inspectors in regulated manufacturing environments.

Culture & Benefits

• Cross-functional collaboration across engineering, manufacturing, quality, maintenance, process development, and network teams.
• Opportunity to support a new facility combining disposable technologies, stainless-steel equipment, Industry 4.0 capabilities, and sustainability initiatives.
• Technical mentoring and participation in global automation and process-control forums.
• Work supporting continuous improvements in manufacturing safety, reliability, efficiency, and environmental performance.