Engineer System Owner - Packaging

Location: Juncos, Puerto Rico, United States

Company

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

What you will do

• Optimize packaging systems and manufacturing processes through engineering analysis, technical solutions, and continuous improvement.
• Support or lead deviations, CAPAs, technical assessments, change controls, periodic reviews, and internal or external audits.
• Develop maintenance strategies, monitor equipment reliability metrics, and manage the equipment lifecycle and work orders in Maximo.
• Conduct root cause investigations, execute equipment testing protocols, and analyze data to support technical decisions.
• Review and create validation protocols, reports, design documents, SOPs, data integrity assessments, and other engineering procedures.
• Collaborate with QA, Validation, Facilities, project managers, consultants, engineers, and vendors on system modifications and equipment improvements.

Requirements

• Master’s degree in Engineering, or Bachelor’s degree in Engineering with at least 2 years of engineering experience.
• Experience in a GMP-regulated pharmaceutical, medical device, or biotechnology environment is preferred.
• Knowledge of packaging equipment, process characterization, validation, monitoring, and optimization techniques is preferred.
• Experience with root cause investigations, CAPAs, change control, technical impact assessments, statistical analysis, and Design of Experiments is preferred.
• Effective verbal and written communication in both Spanish and English is preferred.
• Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays, is preferred.

Nice to have

• Experience supporting New Product Introductions involving packaging equipment recipes, Systech vision system configurations, labeling, serialization, and manufacturing documentation.
• Strong technical report-writing, organizational, communication, and problem-solving skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, and disability insurance for eligible employees and dependents.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable to the work location type.