Senior Engineer - AML6 System Owner

Are you looking for a challenging new opportunity to test and growth your engineering skills? We have an immediate need for a seasoned Sr Engineer to join AML6-Drug Substance team. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The role

If you're the right person for this opportunity you will have a passion for mechanical design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams. We seek a hands-on problem solver, standout colleague, and someone comfortable within an innovative, fast paced environment.

As System Owner you will have a meaningful role for AML6 facility by leading the characterization of process optimization strategies and/or solving operational issues in the operations, manufacturing, pilot plant or capital projects environment.

In addition you will be accountable to apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.

You will also be involved in the developing, organization, analysis and interpretation of results for operational issues or engineering projects of significant scope and complexity. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft even-more efficient methods and processes around the facility. You will also assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team.

Additional objectives are:

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Being the author or provide support in the revision of engineering policies and procedures that affect multiple organizational units.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in the area of chilled water and HVAC, with overall responsibility for determining methodologies in that area.
• Application of mature engineering knowledge in planning and conducting projects.
• To be successful, you will require strong collaboration and partnership cross functionally to implement corrective actions or planned enhancements or representing the production team.
• Capable of operate under a culture of problem solving and continuous improvement.

The department

The AML-6 Facility is the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world.

Basic skills and education needed

Doctorate degree in Engineering

OR

Master's degree in Engineering & 3 years of GMP regulated industry experience

OR

Bachelor's degree in Engineering & 5 years of GMP regulated industry experience

Beyond that, you will also need:

• Educational background in Biomedical, Mechanical, Chemical and/or Electrical Engineering.
• Working knowledge of chemical/pharmaceutical/biotech manufacturing processes or maintenance.
• Proficiency on Cell Culture, Purification and or clean utilities equipment, including troubleshooting and equipment reliability.
• Established expertise in at least 3 separate areas of engineering technology.
• Familiarity with validation and documentation processes in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Excellent presentation and communication skills in Spanish and English languages.
• Process improvement knowledge and Operational Excellence mindset
• Ability to apply engineering science and solutions to maintain production schedules.
• Able to develop quick science based solutions to routine technical problems of limited scope.
• Comprehensive understanding of validation protocol execution requirements.
• Strong interpersonal skills including tact, diplomacy, and flexibility to work effectively with senior leadership, management, peers and staff.

Our team members are passionate about growth, innovation and collaboration. We are constantly striving to improve and better ourselves so that we can better support Amgen's mission. If you have growth mindset and you thrive under pressure, you are probably a great fit for our team!

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes health insurance benefits, performance bonus an award-winning retirement plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on 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.

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.