Senior Engineer, System Owner Compliance (Biopharmaceutical)

Location: US - North Carolina - Holly Springs

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

Company

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

What you will do

• Own biopharmaceutical facility compliance programs and support engineering improvements, system upgrades, equipment design, construction, startup, and validation.
• Develop maintenance programs, manage spare-parts availability, troubleshoot systems, and reduce production downtime.
• Lead Facilities Quality & Compliance programs and maintain systems, utilities, documentation, and engineering activities in a state of inspection readiness.
• Own deviations, change controls, and CAPAs from initiation through investigation, corrective action, and effectiveness verification.
• Support commissioning, qualification, lifecycle management, new product introductions, and engineering documentation.
• Lead continuous-improvement initiatives using Lean, Six Sigma, operational excellence, and data-driven decision-making.

Requirements

• On-site work in Holly Springs, North Carolina, United States.
• High school diploma/GED with 10 years of engineering experience, an associate’s degree with 8 years, a bachelor’s degree with 4 years, a master’s degree with 2 years, or a doctorate.
• Bachelor’s degree in Chemical or Mechanical Engineering and 6+ years of relevant experience, including 5+ years in biopharmaceutical operations or manufacturing, preferred.
• Experience with regulated environments, cGMP quality systems, change control, non-conformances, CAPAs, qualification, and validation.
• Experience with engineering design and implementation, capital projects, commissioning, construction, startup, and validation in GMP manufacturing facilities.
• Strong technical leadership, communication, technical writing, teamwork, and problem-solving skills; flexibility to support 24/7 operations and occasional domestic or international travel.

Nice to have

• Experience with data analytics, root cause analysis, statistical process control, Six Sigma, or predictive maintenance.
• Familiarity with OSHA, EPA, engineering risk assessments, and safety requirements in GMP production facilities.

Culture & Benefits

• Collaborative, innovative, science-based, and team-oriented work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus, stock-based long-term incentives, and paid time-off programs.
• Career development opportunities and flexible work models where applicable.