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Amgen
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.
Specialist IS Business System Analyst
What you will do
Let’s do this. Let’s change the world. In this vital role you will be a part of Amgen’s R&D Veeva Vault Platform Team, working closely with Business collaborators, Product Owners, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. You will support continuous improvements and automation within the Veeva Vault Platform Team and the Hosted Applications. This position combines technical expertise, validation experience, and a solid understanding of regulatory requirements.
The role also demonstrates domain and business process expertise to drive ongoing improvements to validation and meets Amgen’s regulatory and validation procedures. This role also involves working closely with developers and business analysts to ensure that the technical requirements for upcoming developments are thoroughly elaborated and validated.
Roles & Responsibilities:
Collaborate with System Architects and Product owners to manage Validation Strategy and Deliverables for Amgen’s R&D Veeva Vault Platform and its Hosted Applications.
Develop and manage test cases, protocols, and validation documentations within the Veeva Validation Manager Vault.
Provide experienced technical support in validation to meet objectives of quality, output, and cost in developing, troubleshooting, standardizing, and improving new and existing validation methods/procedures.
Prepare, implement, document, and report validation protocols in line with GxP and other regulatory requirements and standards.
Ensure that all validation test procedures are in line with current technology, corporate, and governmental regulations.
Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate.
Implement test scripts to ensure system compliance with regulatory requirements and organizational standards.
Identify, document, and track defects during the testing process.
Collaborate with development teams to resolve defects and validate fixes.
Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards.
Maintain comprehensive audit trails and validation documentations to support regulatory inspections.
Configure and optimize workflows within the Validation Manager Testing Vault to streamline test management and approval processes.
Partner with quality assurance, IT and business teams to ensure alignment on validation objectives and testing requirements.
Act as a liaison between technical teams and customers to ensure system requirements are met.
Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes.
Offer ongoing support to ensure effective use of the platform.
Generate reports and dashboards to monitor testing progress, defect trends, and validation status.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Master’s degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT or related field OR
Bachelor’s degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field OR
Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT or related field.
Solid understanding of Veeva Clinical Platform and business process
6-8 years of Global Pharmaceutical industry experience
Solid understanding of pharmaceutical clinical operation and data management business processes
Experienced in pharmaceutical regulations and specifications
Solid understanding of GxP regulations, specifically 21 CFR Part 11.
Expertise in defining and implementing validation strategies aligned with regulatory requirements.
Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)).
Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity.
Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager, Vault, etc.
Preferred Qualifications:
Proficiency in automation tools and validation software.
Experience of DevOps, Continuous Integration, and Continuous Delivery methodologies.
Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile, etc.).
Professional Certifications:
Veeva Vault Platform Administrator (mandatory)
SAFe – DevOps Practitioner (preferred)
SAFe for teams (preferred)
Soft Skills:
Able to work under minimal supervision.
Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work.
Excellent analytical and gap/fit assessment skills.
Strong verbal and written communication skills.
Ability to work effectively with global, virtual teams.
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Team-oriented, with a focus on achieving team goals.
Strong presentation and public speaking skills.
Shift Information:
This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.
What you can expect of 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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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.
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