Amgen Senior Associate Information Systems Engineer – IBM DOORS in Tampa, Florida
Main job responsibilities for a Senior Associate Information Systems Engineer:
You will work within a multi-functional organization to implement and support both the “In Silico” computer simulation and modeling software lifecycle management solutions as well as the IBM Dynamic Object Oriented Requirements System (DOORS) application which supports drug delivery device / combination product design, development, and commercialization at Amgen.
You will collaborate with functional representatives from quality, regulatory affairs, risk management, and technical / engineering.
You will be expected to:
Establish a working knowledge / an actionable understanding of Amgen’s internal procedures and processes for drug delivery device / combination product development;
Engage key partners to identify and document user needs;
Translate user needs into IBM Rational-based solutions supporting product and platform development teams;
Implement (and validate) IBM Rational-based solutions supporting product and platform development teams;
Maintain IBM Rational-based solutions supporting product and platform development teams;
Identify areas for system improvement, to better support business processes in Process Development
Develop and maintain project schedules, prepare management reports
Bachelor’s degree and 2 years of Information Systems experience
Associate’s degree and 6 years of Information Systems experience
High school diploma / GED and 8 years of Information Systems experience
You are a self-motivated and collaborative problem-solver with a broad medical device and / or combination product development experience. You are a holistic thinker with the following skill sets and expertise:
Knowledge of cloud-based architecture and troubleshooting, ideally with previous AWS experience
Understand database storage and configuration fundamentals
Understand Windows and Unix server configuration basics
5 plus years of experience with IBM Rational DOORS, DOORS Next Gen Team Concert, Quality Manager and the IBM Rational Collaborative Lifecycle Management suite.
Subject-matter expertise in IBM Rational Publishing Engine
Experience programming for OSLC
Experience programming extension API widgets for the Rational CLM suite
Experience creating reports using JRS
Understands Agile methodology for product development
Understand the fundamentals of medical device or combination product systems engineering, risk management and lifecycle management.
Ability to work with multiple user requests simultaneously
Ability to synthesize business and technical constraints and requirements
Provide architectural oversight for system changes and support, identify and mitigate risk regarding system performance and capacity
Skills similar to Product Lifecycle Management (PLM) and Electronic Laboratory Notebook (ELN) tools
Experience in product design/development (design control) from concept to post product launch for US (FDA/PMA/510k) and Europe Union (EMEA/CE Mark) submissions
You should also have experience with the following:
GMP qualification requirements – Installation Qualification, Operation Qualification, Performance Qualification (IQ, OQ, PQ)
21 CFR 820
21 CFR 820.30
EU Medical Device Requirements
Medical Devices Directive 93/42/EEC
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering creative 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 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.
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.