Sr Associate IS Bus Sys Analyst

Career Category

Information Systems

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Business Systems Analyst

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

What you will do

Let’s do this. Let’s change the world. In this vital role you will join our ANC DTI (Digital Technology & Innovation) team to help drive productivity through the company by creating opportunities to stop, optimize processes and then implement and automate as appropriate

Responsibilities:

• Support business and DTI partners to implement and support automation, infrastructure, business and platforms that achieve business objectives

• Responsibilities include process and computer systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, developing, testing and communicating business cases for proposed solutions, and serving as the lead throughout and post implementation.

• Support computerized system compliance initiatives and be the change and release agent for all computerized system compliance activities on the automation, business and analytical platforms ensuring that platforms adhere to Amgen corporate, GxP and SOX compliance requirements

• Support computer validation testing initiates with oversight of project. resources and analysis of test results and preparation of summaries

• Engage with key vendors and platform owners to understand functionality and how those platforms can be used to tackle compliance or business problems

• Structure and standardize processes that can be used across the various platforms for scalability, efficiency, and growth

• Develops and maintains policies, standards, user guides and guidelines across the platforms

• Support release management & Engagement of all Platforms in the team

• Ensuring adherence to Amgen and regulatory standards and procedures for computerized systems

• Provide guidance and set standards in producing quality documentation, serving as liaison between DTI and Quality functions

• Support Data Integrity efforts for automation, business, infrastructure and analytical platforms

• DTI compliance support for automation, business, infrastructure and analytical platforms ensuring they remain in a validated compliant state to support inspection readiness.

• Work and collaborate with the DTI system owners and business owners to determine the best solutions for the system to ensure they remain compliant.

• You will be a participant in all phases of the Computerized Systems Lifecycle including, business client expectation and requirement documentation, process and systems analysis, and articulating system solutions and approaches for addressing business needs pertaining to cross-systems integration requirements and design.

• You will also drive strategic multi-functional meetings to facilitate the optimization of systems through implementation of solutions that enable automation to improve or remain in compliant way

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.

Basic Qualifications:

Master’s degree

OR

Bachelo