Specialist Computer Systems Validation Engineer

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Computer Systems Validation Engineer

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will join our ARI (Amgen Rhode Island) DTI (Digital Technology & Innovation) (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 :

• Serve as a lead with business and DTI partners for 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

• Develop an expert-level understanding of the computer systems platforms, processes, and procedures with a strong emphasis on 'As Is' process and systems mapping, 'To Be' visioning, and identifying and articulating business and DTI functional gaps

• Lead 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 carry out to Amgen corporate, GxP and SOX compliance requirements

• Lead 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

• Ensuring alignment 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

• Data integrity, compliance, and inspection readiness lead for site computer systems platforms

A day in the life :

• You are leading from the front engaging with business functions across the company to identify bottlenecks in their business process

• You also will 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

• Highlight value of data integrity throughout the business, leading and maintaining compliance for computer systems platforms

About the Team :

The ARI DTI team is part of the Digital Technology and Innovation organization at Amgen that is focused on helping improve staff experience, unlock productivity and improving quality leveraging technology to identify inefficient processes, foster simplification of processes and help automate these revised processes to unlock value. This is a highly visible team with a remit to help shape the future pipeline of Amgen products by unlocking value.

Our customers include Amgen staff and various organizations within functions such as Amgen’s internal and external digital and quality community across the globe. Our teams are groups of high-energy, motivated doers that want to improve the lives of our partners through continuous productivity improvement via the use of automation, business, and analytical software technologies.

Win

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:

Doctorate degree

Or

Master’s degree and 3 years of Information Systems or Engineering experience

Or

Bachelor’s degree and 5 years of Information Systems or Engineering experience

Or

Associate degree and 10 years of Information Systems or Engineering experience

Or

High school diploma / GED and 12 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. Aggressive and confident in raising action points with senior individuals with excellent spoken and written communication.

• 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 documents, user documentation, and SOP’s. Ability to quickly assimilate knowledge of new platforms, languages, tools, and technologies

• Strong validation lifecycle Management and Data Integrity experience applying to computer systems (I.e., Business, Automation and Analytical Systems)

• Continuous improvement approach (i.e., LEAN, Kaizen, Six Sigma etc.)

• Experience with SAFe (Scaled Agile Framework) and traditional Agile methodology coupled with strong GxP experience and knowledge on regulations FDA (Food & Drug Administration) Title 21 CFR (Code of Federal Regulations) Part 210 and 211.

• Possess general knowledge of enterprise systems (e.g., Workday, Salesforce, Service Now, SAP)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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

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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.