29 days old

Sr Engineer - New Products/Projects

Juncos, Puerto Rico 00777
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Job ID: R-98325
Location: Juncos, PR, US 00777

Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Sr Engineer to join AML's 1 Inspection and Packaging Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Sr Engineer for New Product Introduction role provides and/or directs the assessment and characterization of new product introduction process. Applies advanced and diverse engineering principles to the introduction of major system modifications, experiments, process and/or capital projects/NPIs. Develops, coordinates, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.


  • Provide Change Control Assessment to support New Product Introductions and International Launches
  • May act as a Change Control Owner/CAPA/NC owner for projects
  • Generate, Review and/or execute Work orders associates to Change controls
  • Generate, Review, Approve and execute functional test protocol to support new product introduction
  • Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
  • Employ sophisticated engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
  • Apply knowledge of engineering principles and practices outside of area of field expertise to broad variety of assignments in related fields.
  • Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Application of mature engineering knowledge in planning and conducting projects.

Basic Qualifications

Doctorate degree in Engineering


Master's degree in Engineering and 3 years of manufacturing experience in GMP regulated environment


Bachelor's degree in Engineering and 5 years of manufacturing experience in GMP regulated environment

Preferred qualifications

  • Project Management Skills
  • Packaging Serialization Knowledge
  • New Product Introduction experience
  • Written and Verbal communications skills in Spanish and English
  • MAXIMO Knowledge is a plus
  • Trackwise Expertise
  • Solid understanding of pharmaceutical/biotech processes
  • Experience with documentation techniques in a highly regulated environment
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to apply engineering science to production.
  • Able to develop solutions to routine technical problems of limited scope
  • Demonstrated skills in the following areas:
  • Problem solving and applied engineering techniques
  • Technical report writing skills
  • Comprehensive understanding of validation protocol execution requirements.
  • Demonstrated Skills in the following areas:
  • Presentations skills
  • Organization
  • Dealing with and managing change
  • Technical (Equipment Specific)
  • Analytical Problem Solving
  • Computer Literacy
  • Specialized equipment/process expertise
  • In-depth knowledge of validation processes and requirements as applied to new equipment installations
  • Interacts effectively with variety of communication and working styles
  • Ability to independently determine when additional internal resources are required to solve problems
  • Ability to prioritize different projects at one time
  • Demonstrated Skills in the following areas:
  • Schedule development
  • Established expertise in at least 3 separate areas of engineering technology.
  • Ability to independently determine when additional external resources are required to solve problems
  • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
  • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
  • Solid understanding of financial analysis tools
  • Ability to delegate and manage the project work of others
  • Demonstrated Skills in the following areas:
  • Negotiation, persuasion and facilitation
  • Collaboration
  • Project cost development
  • Conflict Resolution
  • Leadership skills
  • Management of contractors and vendors

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us passionate about your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.



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Posted: 2020-04-29 Expires: 2020-05-30

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Sr Engineer - New Products/Projects

Juncos, Puerto Rico 00777

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