Lead Packaging Systems Engineer | GMP & QC-Driven

Biopharma Careers; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen in the United States is seeking an Engineer System Owner - Packaging to apply engineering expertise to optimize packaging systems, develop technical docs, and drive operational excellence in a GMP environment.

You will lead deviations, CAPAs, change controls, and work with QA, Validation, Facilities to ensure equipment reliability and documentation integrity. Maximo lifecycle management, cross-functional collaboration, and strong reporting skills are essential.

Qualifications

• Master's degree in Engineering or equivalent.
• GMP-regulated pharmaceutical/biotech packaging experience preferred.
• Proficient technical report writing and bilingual Spanish/English communication.

Responsibilities

• Support or lead deviations, CAPAs, change controls, and periodical reviews.
• Lead corrective and preventive actions to improve packaging processes and validate effectiveness.
• Develop maintenance strategies to improve equipment reliability and monitor KPIs.
• Conduct root cause analysis and document findings for investigations.
• Review and update validation protocols, design documents, SOPs, and data integrity assessments.
• Collaborate with QA, Validation, Facilities to define system modifications and ensure compliance.
• Manage equipment lifecycle using Maximo and coordinate with vendors and external consultants.

Skills

Report writing

Bilingual English/Spanish

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering + 2 years experience

Tools

Maximo

Job description

Amgen in the United States is seeking an Engineer System Owner - Packaging to apply engineering expertise to optimize packaging systems, develop technical docs, and drive operational excellence in a GMP environment.

You will lead deviations, CAPAs, change controls, and work with QA, Validation, Facilities to ensure equipment reliability and documentation integrity. Maximo lifecycle management, cross-functional collaboration, and strong reporting skills are essential.