Sr Engineer

Job Summary

The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods and container closure integrity test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

Basic Qualifications:

Doctorate Degree OR

Master's Degree and 3 years of Engineering experience

OR Bachelor's Degree and 5 years of Engineering experience

OR Associate's degree and 10 years of Engineering experience

OR High school diploma/GED and 12 years of Engineering experience.

RESPONSIBILITIES:

• Assure transfer of new combination product test methods or container closure integrity methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
• Execute test method development, qualification, and transfer per procedures to ensure projects are completed on schedule and within established budget.
• Provide expert support in the design or redesign of tools and/or equipment required for manufacturing testing and/or processes.
• Provide expert support for investigations as well as new process development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
• Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
• Supervise work of support staff during development and manufacture of test methods.
• Generate/author and own the Combination Product Test Method documents.
• Ensure test method test fixtures, processes, and equipment operate safely and considers ergonomic factors in the design
• Excellent communication (written and verbal) and organizational skills
• Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
• Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen
• Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
• Communicates project status and risks associated with integrated timelines to leadership
• Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
• Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
• Integrates partner/vendor timelines with Amgen timelines as appropriate

The position will require approximately 10% travel to international locations assisting our development partners during implementation of mechanical engineering methods into their processes.

Preferred Qualifications:

• M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
• Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
• Experience with managing technical teams, including setting priorities and leveling resources
• Technical writing experience
• Spanish language skills preferred
• Experienced with SolidWorks (or other 3D-CAD software)
• Familiar with equipment and softward IOQ
• Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
• Experience with change controls, deviations, CAPA
• Experience with combination products and device regulatory requirements
• Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
• Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
• Experience with machine controls (PLC, HMI) and vision systems

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 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 all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.