Validation Specialist – Computerized System – Safety Digital

Validation Specialist Computerized System Safety Digital Technology & Innovation

The Safety DTI team plays a vital role in supporting Amgens Global R&D by delivering information services that optimize the safe use of Amgen products. Our efforts focus on continuous benefit-risk assessment, effective communication, and providing regulatory and safety intelligence throughout the development, registration, and lifecycle management of Amgens molecules. As a key member of our team, you lead the Computer software Assurance (CSA) efforts, ensuring the rigorous testing and, when necessary, validation of risk-based software solutions. Your role is critical in verifying that these solutions meet both functional and technical requirements, thereby upholding the highest standards of quality for the intended outcomes.

• Collaborates with internal teams, including IS functions (Infrastructure, ITIL process owners), external service providers, Corporate Quality, and Pharmacovigilance Safety business units.
• Responsible for supporting the planning, design, and implementation of system testing and validation.
• Leads or develops validation plans, validation strategy, test scripts, and 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
• Leads Change Approval Board and ensures all changes follow the accurate 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 on Computer Software Validation (CSV) and Computer Software Assurance (CSA)
• 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
• Excellent verbal and written communication skills, including strong business writing abilities and active listening
• Independent decision-making ability with strong conceptual thinking and conflict resolution skills, and the capacity to effectively manage and resolve disputes.
• Provide guidance on compliance issues related to computerized systems and ensure continuous improvement of validation processes.
• Support regulatory inspections and audits, ensuring all validation activities
• Stay informed on industry trends, regulatory changes, and advancements in digital technology to continuously improve validation practices.

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Masters degree and 4 to 6 years of Information Systems experience OR
• Bachelors degree and 6 to 8 years of Information Systems experience OR
• Diploma and 10 to 12 years of Information Systems experience

Preferred Qualifications:

• Demonstrated leadership in validation activities for complex IT GxP projects, with a preference for experience in validating PV ecosystems (e.g., ARIS Global and/or Oracle Argus); ITIL Change and Problem Management expertise.
• Expertise in the Software Development Process (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP 5 requirements, particularly their relevance to PV systems (GCP Guidelines).
• Hands-on experience in authoring, reviewing, and approving computer system validation artifacts.
• Problem-solving skills, with experience in Root Cause Analysis, Non-Conformance, and Deviation investigations.
• Proficiency with Quality Management Software and Processes.
• Proficiency in change control process
• Experience in authoring Validation Plans, Requirements/Design Specifications, Installation Qualification protocols, Traceability Matrices, and Validation Summary Reports for assigned projects.
• Extensive experience across all aspects of the Software Development Lifecycle, including requirements, design, testing, business analysis, data analysis, and Change Control processes.
• Over 5 years of solid experience in a regulated industry, with hands-on software validation expertise.
• Experience with IT Service Management platforms, preferably ServiceNow.
• Experience in supporting regulatory inspections and internal audits.
• High learning agility and adaptability.
• Demonstrable ability to work effectively with dynamic teams and make sound decisions.
• Working knowledge of Veeva Validation tool (VVM), HP Application Lifecycle Management (ALM), Service Now is plus.
• SAFe Agile SCM certification is plus.