Amgen is seeking a Principal Engineer in Process Development (PD) that will report to the Director of Packaging Engineering at its main headquarters in Thousand Oaks, CA.
The Principal Engineer will lead a team of engineers responsible for the clinical and commercial packaging for drug substance, drug product, primary container closures and final product presentations. They will help create and implement the long-term strategy to ensure that Amgen becomes and remains an industry leader in this area. They will work cross functionally as a Device Technology Lead (DTL) within PD and across Amgen to develop products that create a successful patient experience. The Principal Engineer is expected to develop annual goals and strategic direction for the packaging organization. The Principal Engineer will identify and drive efficiencies and utilization of the commercialization process, the life cycle of products, and the overall manufacturing capability of Amgen packaging operations across the global networks.
Design, qualification and implementation of packaging designs
Pursue packaging technologies that will drive innovation and gain efficiencies in the network
DTL lead for molecule programs driving packaging final drug product strategy and milestone to the Product Delivery Teams
Deliver results aligned with departmental and program goals
Drive continuous improvement in the packaging processes from project initiation through launch, as well as, life cycle management in alignment with regulatory and commercial manufacturing requirements
Develop and maintain a high performing team of engineers, with advanced degrees and experience in packaging engineering that are professionally and technically competent
Identify resource requirements to deliver on program portfolio and negotiate resource assignments from leadership
Deliver progress reports and presentations ensuring that management is aware of the current status, progress and future needs within Operations
Identify and ensure areas of responsibility complies with the most current standards and company policies
Author regulatory documents in support of molecule applications
Provide leadership and guidance to ensure consultants, contract manufacturers, and external business partners comply with business standards and requirements
Doctorate degree and 2 years of Engineering experience
Master's degree and 6 years of Engineering experience
Bachelor's degree and 8 years of Engineering experience
Associate's degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience
Ability to lead teams to successful project results within established time guidelines
Excellent leadership, project management, technical problem solving and communication (written and verbal) skills, and the ability to manage remote people, work in teams and adapt to rapidly changing environments
Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge of primary and secondary packaging systems & processes, manufacturing process equipment & processes, material science and quality systems
Excellent organizational, project management, technical, problem solving and communication (written & verbal) skills
Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule
AutoCad or similar software application to create, modify and approve engineering drawings
10+ years of packaging engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in operations and packaging design
3+ years managing a team
3+ years of experience in executing packaging engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, cost/benefit analysis)
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.
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