Process Engineer - CIP/SIP/Autoclave (Biopharmaceutical Manufacturing)

Location: US - North Carolina - Holly Springs

Salary: $88,281–$119,439 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses, including through a new advanced drug substance manufacturing facility in Holly Springs.

What you will do

• Design, build, commission, qualify, and support equipment and systems for drug substance production.
• Provide lifecycle support for CIP skids, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and automation platforms.
• Support GMP commissioning, qualification, startup readiness, routine manufacturing operations, troubleshooting, and continuous improvement.
• Interact with regulatory inspectors and demonstrate compliance of manufacturing systems.
• Support product and technology introductions, engineering assessments, equipment modifications, and engineering runs.
• Develop maintenance programs, manage spare-parts availability, and coordinate maintenance activities.

Requirements

• Master’s degree; or bachelor’s degree with 2 years of engineering experience; or associate’s degree with 6 years of engineering experience; or high school diploma/GED with 8 years of engineering experience.
• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a similar engineering discipline preferred.
• 3+ years of relevant experience, including 2+ years in biopharmaceutical operations or manufacturing preferred.
• Experience with biopharmaceutical production equipment, CIP circuit design and validation, SIP, autoclaves, clean steam, and water for injection.
• Experience with regulated environments and GMP quality systems, including change control, non-conformances, CAPA, qualification, and validation.
• Ability to support 24/7 operations with occasional after-hours coverage and travel domestically and internationally.

Nice to have

• Experience with data analytics, root cause analysis, statistical process control, Six Sigma, or predictive maintenance.
• Experience with capital projects, procurement, construction, startup, validation, and system modifications in GMP facilities.
• Strong technical writing, leadership, communication, presentation, facilitation, and teamwork skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Opportunity to contribute to an advanced manufacturing facility with disposable technologies, stainless steel equipment, industry 4.0 capabilities, and sustainability initiatives.
• Competitive benefits and comprehensive total rewards aligned with local industry standards.
• Inclusive workplace focused on professional growth, well-being, and advancing treatments for serious diseases.