Specialist IS Bus Sys Analyst

Job Description

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.

---