Senior Process Engineer - CIP/SIP/Autoclaves

Location: On-site in Holly Springs, North Carolina, United States; up to 10% domestic and international travel, with rotational on-call or shift support for 24/7 operations.

Salary: $115,494.60–$156,257.40 USD annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Design, build, commission, qualify, and provide lifecycle support for CIP skids, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and automation platforms.
• Support site installation, factory acceptance testing, design reviews, commissioning, validation, engineering qualification, startup readiness, and hypercare.
• Own CIP, SIP, and autoclave process equipment and systems, supporting manufacturing, maintenance, quality, process development, and operations teams.
• Lead equipment troubleshooting, technical root cause analysis, corrective and preventive actions, modifications, upgrades, and continuous improvement initiatives.
• Develop maintenance programs, manage spare-parts availability, coordinate equipment maintenance, and work with original equipment manufacturers.
• Support new product and technology introductions, engineering assessments, performance risk assessments, remediation, and audit readiness.

Requirements

• Doctorate degree; or a master's degree with 2 years of engineering experience; or a bachelor's degree with 4 years; or an associate's degree with 8 years; or a high school diploma/GED with 10 years of engineering experience.
• Degree in chemical engineering, mechanical engineering, or a similar engineering discipline.
• 6+ years of relevant experience, including 5+ years in biopharmaceutical operations or manufacturing.
• Direct experience designing and troubleshooting GMP biopharmaceutical production equipment and systems, including CIP, autoclaves, solution preparation, upstream, and downstream purification equipment.
• Experience with technology transfer, process design, commissioning and qualification, and regulated environments such as cGMP, OSHA, or EPA.
• Ability to work on-site in Holly Springs and support a flexible schedule for 24/7 operations, with limited domestic and international travel.

Nice to have

• Experience with GMP quality systems, change control, non-conformances, corrective and preventive actions, qualification, and validation.
• Strong leadership, technical writing, communication, presentation, facilitation, and teamwork skills.
• Experience supporting solution preparation, cell culture, centrifugation, chromatography, viral filtration, UFDF, clean steam, and water-for-injection systems.

Culture & Benefits

• Work in a new drug substance manufacturing facility combining disposable technologies, stainless steel equipment, and industry 4.0 capabilities.
• Collaborate with corporate engineering, manufacturing, quality, maintenance, process development, and global engineering groups.
• Contribute to sustainability initiatives designed to reduce carbon emissions and waste.
• Participate in a science-based, collaborative, and innovation-focused work environment.