Career CategoryEngineering
Job DescriptionEngineer System Owner - PackagingWhat you will doLet'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.
What we expect of youWe 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 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
What you can expect of usAs 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.
Apply now and make a lasting impact with the Amgen team. careers.amgen.comIn 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.
SponsorshipSponsorship 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.
