Engineer - Line System Owner AML 14 - Inspection
Engineer - Line System Owner AML 14 - Inspection
US - Puerto Rico - Juncos Apply NowJoin 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. 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 - Line System Owner AML 14 - Inspection
What you will do
Let’s do this. Let’s change the world. In this vital role you will, under general to minimum supervision, be the system owner responsible to oversight process equipment in the inspection area. In addition, you will also apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
Specific responsibilities include but are not limited to:
- Act as Equipment System Owner for Inspection or Vial Business Units.
- Analyze and present results to address operational issues and engineering projects.
- Collaborate with maintenance teams to develop solutions for moderate technical challenges, ensuring commercial requirements are met.
- Provide manufacturing support, including nonconformance resolution and process monitoring.
- Oversee inspection equipment performance and collaborate with Product Development to prioritize and execute inspection optimizations aligned with business needs.
- Assess the technical impact of non-conformances and recommend corrective/preventive actions.
- Apply standard engineering techniques and procedures under supervised guidance.
- Serve as a technical support contact for equipment troubleshooting and reliability improvements.
- Collaborate with Maintenance to ensure effective maintenance activities and critical spare parts' availability.
- Engage in daily operations to meet schedules and resolve complex problems.
- Audit equipment performance and regulatory compliance for moderately complex systems.
- Support new product introductions, regulatory filings, and inspections.
- Drive process optimization to improve cost efficiency, capacity, and robustness.
- Collaborate with departments such as research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation to develop system modification recommendations.
What we expect of you
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 & 2 years of engineering or manufacturing support experience
Preferred Qualifications:
- Experience working in a GMP environment within the pharmaceutical, medical device or biotechnology company
- Expertise in parenteral inspection processes.
- Familiarity with inspection equipment, process characterization, validation, monitoring, and optimization techniques.
- Proficiency in statistical analysis and design of experiment (DOE) methodologies.
- Proficiency in applying engineering principles to solve technical problems and work in production environments.
- Skill in developing solutions for routine technical problems of limited scope.
- Strong problem-solving abilities.
- Proficiency in technical report writing.
- Effective communication skills, both verbal and written, in Spanish and English.
- Availability for non-standard shifts, including extended hours, nights, weekends, and holidays.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and an annual site shutdown
- Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.