Amgen

Senior Associate Information Systems Engineer - IBM DOORS

Employer
Amgen
Location
Tampa, FL, US
Posted
Jun 12, 2019
Ref
R-77866
Required Education
High School or equivalent
Position Type
Full time
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.

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


Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Information Systems experience

OR

Associate's degree and 6 years of Information Systems experience

OR

High school diploma / GED and 8 years of Information Systems experience

Requirements and Skills:

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+ years' 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 will 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
  • ISO 13485
  • ISO 14971
  • EU Medical Device Requirements
  • Medical Devices Directive 93/42/EEC


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 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.