Sr Associate IS Bus Sys Analyst - OneTen Coalition

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

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

Preferred Qualifications:

• Strong customer service focus with the demonstrable ability to develop and maintain effective working relationships with team members, partners, and management. Demonstrate strong collaboration across all levels of the organization. Assertive and confident in raising action points with senior individuals with excellent spoken and written communication.
  
• 2+ years of experience supporting business process analysis with business owners and SMEs across multiple geographically disbursed teams
  
• Experience performing and documenting business processes redesign and aligning business requirements to technical solutions
  
• Strong verbal and presentation communication skills and ability to engage with varying levels of audience both technical and non-technical
  
• Experience writing and publishing internal white/position papers, user documentation, and SOP's.
  
• Domain knowledge of health care/life sciences would be a plus
  
• Strong Data Integrity experience applying to Business, Automation and Analytical Systems
  
• Validation Lifecycle Management expertise
  
• Automation, Business and Analytical systems experience delivering value
  
• Continuous improvement approach (i.e., LEAN, Kaizen, etc.)
  
• GxP experience and knowledge on regulations FDA Title 21 CFR Part 210 and 211.
  
• Possess knowledge of enterprise systems (e.g., Workday, Salesforce, Service Now, SAP)
  
• Ability to quickly assimilate knowledge of new platforms, languages, tools, and technologies.
  

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  
• Stock-based long-term incentives
  
• Award-winning time-off plans
  
• Flexible work models, including remote and hybrid work arrangements, where possible
  

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.