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Job Description

HOW MIGHT YOU DEFY IMAGINATION?
 

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Computer Systems Validation Analyst Analyst

Remote Work

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will join the Safety & Global Regulatory Affairs and Strategy (GRAAS) Digital, Technology and Innovation (DTI) team within Global R&D. We deliver information services enabling the optimization of the safe use of Amgen products through continuous benefit: risk assessment and communication as well as providing regulatory and safety intelligence for the development, registration, and lifecycle management of Amgen’s molecules.

As a crucial part of our services portfolio, you will lead our Software Quality Assurance which is to provide the means and measures for testing and – if required – validation of all the aspects of a software solution, both functionally and technically, to meet the requirements and overall quality of the intended solution. In addition, you are covering the roles of Lead Problem Investigator and handling all our system changes.

Responsibilities:

• Works within our team, with supporting Information Systems (IS) functions (Infrastructure, ITIL process owners, etc.), external service providers, Corporate Quality team and business units

• Responsible for supporting the planning, design, and execution of system testing and validation

• Leads or develops test plans, test cases, test scripts and test reports on multiple projects and ultimately validates that expectations of our users are met during the testing process

• Ensures the IS Problem Management process is followed. Drives problem records from initial analysis to final corrective actions/ preventative actions and if required documents Known Errors

• Manages the portfolio of active IS Changes from initiation till closure

• Leads our Change Approval Board and ensures all changes follow the correct process

• Drives advancements of automated testing, based on ongoing analysis of manual testing efforts versus efforts to keep test automation current

• Analyzes and explores industry trends and standard methodologies

• Understands Patient Safety business processes and remains informed about changes in agency regulations

• Defines and leads the change and validation approach for application support & projects

• Generates, reviews, and completes validation work, qualification and validation protocols, summary reports and associated data for conformance to regulations, standard operating policies, specifications, and other applicable acceptance criteria

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The passionate professional we seek is a leader with 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:

• Shown ability to lead validation activities of complex IT GxP projects (preferably experience validating Oracle Argus; ITIL Change and Problem management)

• Possess system quality and compliance working knowledge of GxP regulations (21 CFR Part 11); ICH GCP guidelines; and their applicability to PV systems

• Hands-on authoring/ review/ approval of computer system validation artifacts

• Clear communicator– to ensure ability to directly work with developers and other partners

• Demonstrated ability in problem solving and experience in Root Cause Analysis / Non-Conformance /Deviation investigations

• Experience with Quality Management Software and Processes

• Author Validation Plan, Requirement/Design Specification, Installation, Qualification protocols, Traceability Matrix and Validation Summary Reports for assigned projects

• Understanding of ITIL processes

• In-depth experience in all aspects of Software Development Lifecycle from requirements, design, testing, business analysis, data analysis and Change Control process

• 3+ years strong working experience in a regulated industry and formal (hands on) software validation experience

• Working experience with IT Service Management platforms, preferably ServiceNow

• Knowledge and understanding of Information System infrastructure, system design and architecture as well as service management

• Assist with regulatory inspections as well as the internal audits

• High learning agility

• Experience working with dynamic teams and ability in decision-making

• SAFe Agile CSM certification is an asset

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com