Amgen

Principal Engineer AML6 - Drug Substance

Employer
Amgen
Location
Juncos, PR, US
Posted
Aug 17, 2019
Ref
R-80208
Required Education
Bachelors Degree
Position Type
Full time
Are you looking for a challenging new opportunity to test and growth your engineering skills? We have an immediate need for a Principal Engineering 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 Principal Engineer role will manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes. Employs an extensive technical knowledge of more than one area of engineering (process, unit operations, equipment project) in complex process characterization, optimization, scale-up, or manufacturing support projects

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 high technical leader, and someone comfortable within an innovative, fast paced environment.

As Principal Engineering you will have a meaningful role for AML6 facility by supporting the Engineering Department and day to day operational issues in the manufacturing, pilot plant or capital projects environment.

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:

• Plan, coordinate and implements manufacturing technical service activities which include new product introductions.
• Manage the process of equipment characterization, trouble shooting, validation, and monitoring and data management.
• Interface with Plant Managers, i.e., Production Managers and Senior Process Development staff to assess needs and update progress.
• Establish engineering policies for a major segment of the company.
• Interpret, execute, and recommend modifications to company-wide policies.
• Develop organizational budgets or project budgets encompassing all disciplines for large or complex project.
• Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.
• Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept.
• Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.
• Plan, organize and coordinate work of a staff of engineers and/or technicians.
• Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications.
• Established a corporate Engineering resource, specializing in more than one area of engineering.
• Designs, executes, implements and directs engineering or process projects which significantly contribute to attaining high priority goals.
• Prompt and regular attendance to workplace.
• Development and Execution of Processes Characterization:
o Establish Testing Strategies
o Design / Development of Characterization Protocols
o Technical Reports Development
o Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies.
• Risk assessments and QRAES knowledge, to support risk assessments activities.
• Support extended shift as per business needs.
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 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 Qualifications

Bachelor's degree in Engineering & 8 years of Engineering experience in a regulated industry.
OR
Master's degree in Engineering & 6 years of Engineering experience in a regulated industry.
OR
Doctorate degree in Engineering & 2 years of Engineering experience in a regulated industry.

Beyond that, the preferred qualifications are:

• Educational background in Electrical, Chemical and/or Mechanical Engineering
• Experience leading teams and/or projects.
• Experience on Drug Substance Purification Equipment (Chrom Skids, Chrom Columns, Central CIP Systems, Buffer Preparation)
• Experience in an industrial setting.
• Organizational and project management skills
• Technical problem solving (hardware as well as software)
• Excellent communications skills in English and Spanish (written and verbal)
• Ability to work in teams and adapt to a rapidly changing environment, serving multiple customers and vendors.
• Flexibility to work off-hours.

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.