Process Development Principal Engineer - Drug Product

As part of the Drug Product Technologies group, the process development Principal Engineer will provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Principal Engineer will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on visual inspection unit operations including but not limited to the below processes:

• Drug product manual inspection
• Automated visual inspection
• Semi-automated visual inspection
• Knapp study design and execution
• AQL / ASP design

The Principal Engineer will integrate and utilize platform capabilities, prior product knowledge, and data analytics/visualization to advance Amgen practices and ensure success through the commercialization process.

The Principal Engineer will operate in a fast-paced, matrixed environment and collaborate successfully cross-functionally to lead the implementation of technologies and solve technical challenges in support of multiple modalities across the Amgen network. In addition, effective management of interactions with technology vendors and suppliers will be important in achieving objectives on schedule.

The Principal Engineer will need to stay current on the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs.

This position requires (up to 10%) travel to domestic and international sites

Key Responsibilities:

• Acts as an inspection technical leader to provide solutions when troubleshooting inspection issues
• Interfaces with inspection teams at drug product manufacturing sites and communicates capabilities and site practices to drug product teams
• Work with research, manufacturing, process development, quality assurance and validation departments in leading the development of requirements and recommendations for vision system or inspection process
• Development and leadership of Processes Characterization for inspection systems
• Establish Testing Strategies
• Design / Development of Characterization Protocols
• Technical Reports Development
• Validations, and technical reports- To support SATs/IOQ/PQ executions, document generation and challenge validations strategies
• Risk assessments and QRAES knowledge, to support risk assessments activities
• Leads risk assessment for inspection operations and propose / implement appropriate CAPA
• Identifies and leads the implementation of operational opportunities for current and new inspection operations
• Leads cross-site teams to support the above activities, providing recommendations to management
• Development of Validation Plans, IOQs and PQs
• Ensures that visual inspection operations meet applicable quality requirements and FDA, EU & International Standards
• Lead the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Lead deviation and exception resolution and root cause analysis
• Lead project activities
• Coordinates and organizes resources needed to complete tasks

Basic Qualifications:

Doctorate degree and 2 years of Engineering and/or Operations experience

OR

Master's degree and 6 years of Engineering and/or Operations experience

OR

Bachelor's Degree and 8 years of Engineering and/or Operations experience

OR

Associate's degree and 10 years of Engineering and/or Operations experience

OR

High school diploma/GED and 12 years of Engineering and/or Operations experience

Preferred Qualifications:

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics with experience in applied statistics or Statistics degree with experience in pharmaceutical development and manufacturing
• 5+ years experience in a relevant leadership role
• Experience in cGMP manufacturing environment, knowledge of cGMPs and other worldwide regulatory requirements, and experience in regulatory inspections
• Knowledge of inspection processes, vision systems, Knapp studies, inspection equipment qualifications, manual inspection qualifications
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
• Project management skills, including the ability to manage multiple projects and evaluate project resource requirements
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion and influencing decisions
• Excellent oral and written communications skills

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.