Engineer System Owner - Packaging

Amgen • Juncos, PR

8d

About The Position

Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Engineer System Owner - Packaging
What you will do
Let’s do this. Let’s change the world. In this vital role you will apply engineering expertise to optimize complex systems and processes, develop and maintain technical documentation and drive operational excellence through data-driven decision-making and continuous improvement.
Specific responsibilities include but are not limited to:
Support or Lead on Deviations, CAPAs, Technical Assessments, Change Controls, Periodic Reviews and Internal/External Audits
Lead and execute corrective and preventive actions to enhance engineering controls on the manufacturing processes. Including the Effectiveness Verification of actions
Develop maintenance strategies and controls to improve and maintain equipment reliability by monitoring key performance indicators and metrics.
Conduct root cause analysis and document findings
Develop and execute equipment testing protocols and analyze data to support investigations
Review and update documentation such as validation protocols, design documents, SOPs, and data integrity assessments
Collaborate with peers to ensure quality and compliance of documents. Review and revise documents including data integrity and security assessments, validation protocols and reports, design documents and SOPs.
Create and refine engineering technical supporting documentation and procedures impacting multiple departments or systems.
Apply engineering principles and advanced techniques to develop creative technical solutions
Manage equipment lifecycle and maintenance using Maximo (create, execute, and approve work orders)
Work with cross-functional teams (e.g., QA, Validation, Facilities) to define system/facility modifications
Partner with project managers to ensure projects meet scope, schedule, and quality goals
Coordinate work with external consultants, engineers, and vendors
Engage with vendors to troubleshoot equipment issues and implement improvements
Model a culture of accountability, safety, and continuous learning in alignment with Amgen values.
Proficiency in computer applications such as Word, Excel, PowerPoint, and or data visualization tools.
Strong organizational skills with the ability to manage priorities, document work clearly, and meet project timelines.

Requirements

• Master’s degree in Engineering
• Bachelor’s degree in Engineering and 2 years of Engineering experience

Nice To Haves

• Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry
• Proficiency in technical report writing
• Effective communication skills in both Spanish and English (verbal and written)
• Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques
• Strong problem-solving skills and experience conducting root cause investigations
• Expertise in identifying and managing Corrective and Preventive Actions (CAPAs)
• Proficiency in statistical analysis and Design of Experiments (DOE) methodologies
• Ability to apply engineering principles to solve technical issues in a production environment
• Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays
• Experience supporting New Product Introductions (NPI) by analyzing product and market requirements to assess impacts on packaging equipment recipes, Systech vision system configurations, labeling/serialization processes, and associated manufacturing documentation
• Understanding of Change Control processes, including experience performing technical impact assessments, evaluating the effect of proposed changes on packaging equipment

Responsibilities

• Support or Lead on Deviations, CAPAs, Technical Assessments, Change Controls, Periodic Reviews and Internal/External Audits
• Lead and execute corrective and preventive actions to enhance engineering controls on the manufacturing processes. Including the Effectiveness Verification of actions
• Develop maintenance strategies and controls to improve and maintain equipment reliability by monitoring key performance indicators and metrics.
• Conduct root cause analysis and document findings
• Develop and execute equipment testing protocols and analyze data to support investigations
• Review and update documentation such as validation protocols, design documents, SOPs, and data integrity assessments
• Collaborate with peers to ensure quality and compliance of documents. Review and revise documents including data integrity and security assessments, validation protocols and reports, design documents and SOPs.
• Create and refine engineering technical supporting documentation and procedures impacting multiple departments or systems.
• Apply engineering principles and advanced techniques to develop creative technical solutions
• Manage equipment lifecycle and maintenance using Maximo (create, execute, and approve work orders)
• Work with cross-functional teams (e.g., QA, Validation, Facilities) to define system/facility modifications
• Partner with project managers to ensure projects meet scope, schedule, and quality goals
• Coordinate work with external consultants, engineers, and vendors
• Engage with vendors to troubleshoot equipment issues and implement improvements
• Model a culture of accountability, safety, and continuous learning in alignment with Amgen values.
• Proficiency in computer applications such as Word, Excel, PowerPoint, and or data visualization tools.
• Strong organizational skills with the ability to manage priorities, document work clearly, and meet project timelines.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level