Senior Engineer, Computer System Validation Specialist

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, help us improve the lives of people and animals everywhere.

The Computer System Validation (CSV) Specialist is responsible for implementing Innomar’s CSV strategy and leading validation activities for computerized systems, including hardware and software, that support GxP-impacting business processes. This role ensures ongoing compliance with PIC/S Annex 11 and 21 CFR Part 11 requirements. Responsibilities include prioritizing, executing, maintaining, and coordinating CSV activities; evaluating software applications against design specifications and user requirements;

and serving as a liaison between IT, operational business units, QA, and external partners, where applicable. The CSV Specialist also supports software and application testing and ensures project expectations are clearly defined and met in accordance with company policies and procedures. This position reports to the QA Testing & Validation Team Lead or Manager.

• Implement Innomar’s CSV strategy and lead validation efforts for GxP-impacting computerized systems, ensuring compliance with PIC/S Annex 11 and 21 CFR Part 11 requirements is established and maintained.
• Review and/or develop validation strategies and associated documentation in alignment with Innomar’s CSV Policy, CSV procedures, and Validation Master Plan to support compliance and business objectives.
• Prepare validation documentation packages for CSV projects, including Validation Plans, Requirements Traceability Matrices, Risk Assessments, IQ/OQ/PQ protocols, test cases, Validation Summary Reports, change controls, and SOPs.
• Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
• Design, create, execute, and review risk-based test cases, including functional, integration, challenge, regression, and other applicable tests, and prepare test data to support validation activities.
• Provide guidance and support to validation team members, operational business units, IT, and third-party vendors in developing validation deliverables, including User Requirements Specifications, Part 11/Annex 11 assessments, Functional Requirements Specifications, and design specifications.
• Obtain and review unit test documentation from IT development teams or vendors, where applicable, to confirm code released to the test environment has been adequately unit-tested prior to QA validation activities.
• Manage defects, deviations, and incidents identified during validation projects, including:
• Log deviations and incidents identified during IQ, OQ, and PQ activities.
• Organize defect, deviation, and incident triage meetings with required stakeholders to determine resolution plans.
• Maintain and update defect, deviation, and incident logs with appropriate status through project closure and filing.
• Coordinate validation and qualification documentation review, approval, execution, and post-execution review activities.
• Maintain and archive CSV documentation to support effective retrieval when required.
• Coordinate with IT, QA, and applicable business units to train validation project team members on testing and validation policies, practices, and tools, including formal training materials, one-on-one coaching, and classroom training where needed.
• Provide quality guidance and assessments to ensure validated systems are maintained and changed in accordance with current corporate and regulatory requirements.
• Conduct QA audits of IT and validation processes as scheduled.
• Review and provide input to CSV-related Standard Operating Procedures and policies, where required, and ensure adherence to internal SOPs and applicable regulatory requirements.
• Keep current with relevant industry and regulatory guidelines.
• Comply with all appropriate policies, procedures and safety rules and regulations.

This job profile description is a standardized,…