System Validation Expert

Job Title: Business System Analyst - Validation Specialist

The position requires collaboration with system architects and product owners to develop a validation strategy for Amgen's R&D Veeva Vault Platform and its hosted applications.

Key Responsibilities:

• Create test cases, protocols, and validation documents within the Veeva Validation Manager Vault.
• Provide 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.
• Evaluate all validation test procedures to ensure they align with current technology, corporate, and governmental regulations.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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.
• Evaluate all testing and validation activities to ensure alignment 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.
• Serve as a liaison between technical teams and customers to ensure system requirements are met.
• Deliver training to end-users on Veeva VM Testing Vault functionalities and standard processes.
• Provide ongoing support to ensure effective use of the platform.
• Generate reports and dashboards to monitor testing progress, defect trends, and validation status.

Requirements:Basic Qualifications:

• A Master's degree with 4-6 years of experience in Computer Science, Business, Engineering, IT, or a related field.
• A Bachelor's degree with 6-8 years of experience in Computer Science, Business, Engineering, IT, or a related field.
• A Diploma with 10-12 years of experience in Computer Science, Business, Engineering, IT, or a related field.
• Understanding of the Veeva Clinical Platform and business processes.
• Global Pharmaceutical industry experience.
• Understanding of pharmaceutical clinical operation and data management business processes.
• Familiarity with pharmaceutical regulations and specifications.
• 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.

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.

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.
• 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.

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