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Puerto Rico, United States
Onsite
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
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.
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.
We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual contributor with these qualifications.
Basic Qualifications:
Master’s degree in Engineering
OR
Bachelor’s degree in Engineering and 2 years of Engineering experience
Preferred Qualifications:
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
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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. Refer to the Work Location Type in the job posting to see if this applies.
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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