Specialist IS Bus Sys Analyst

ollaborate 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

Basic Qualifications:

• Master's degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT, or a related field OR
• Bachelor's degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT, or a related field OR
• Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT, or a related field.
• Solid understanding of the Veeva Clinical Platform and business processes.
• 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 with 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.