Senior Associate Manufacturing Manufacturing Investigations (Biotechnology)

Location: Holly Springs, North Carolina, United States

Company

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

What you will do

• Manage simple deviation and environmental monitoring investigations within the controlled environmental monitoring area.
• Lead root cause analysis, CAPA development, and compliant documentation of investigation findings.
• Interpret environmental monitoring data, identify trends, and assess potential impacts on product quality, manufacturing operations, and contamination control.
• Coordinate cross-functional investigations with manufacturing, process development, facilities and engineering, automation, EHSS, and quality teams.
• Present investigation findings and technical information to regulatory inspectors, internal auditors, management, and other stakeholders.
• Develop tracking tools and use Operational Learning Team strategies to improve collaboration and ensure timely investigation closure.

Requirements

• High school diploma/GED with 4 years of manufacturing or regulated-environment experience, or an associate degree with 2 years of experience, or a bachelor's degree with 6 months of experience, or a master's degree.
• Experience in biologics drug substance manufacturing and microbiological investigations.
• Understanding of environmental monitoring programs, contamination control principles, and basic microbiology.
• Experience with compliance, critical thinking, quality systems, project management, and root cause analysis tools such as 5 Whys and fishbone analysis.
• Strong written and verbal communication skills, technical writing ability, and experience working in a matrix environment.
• Experience leading investigations and using Veeva QMS for deviation investigations and CAPAs is preferred.

Nice to have

• Three or more years of related experience in manufacturing, microbiology, process development, or quality assurance within the biotechnology or pharmaceutical industry.
• Degree in science or engineering, with microbiology or a similar discipline being advantageous.

Culture & Benefits

• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus program and stock-based long-term incentives.
• Award-winning time-off plans and biannual company-wide shutdowns.
• Flexible work models, including remote arrangements where possible.
• Career development opportunities and a collaborative, cross-functional work environment.