Validation Engineer - Katalyst Healthcares & Life Sciences

• Collaborate with stakeholders to gather and define requirements for validation activities
• Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Perform risk assessments to identify critical and non-critical systems and validate accordingly
• Create and maintain validation documentation, such as Validation Plans, User Requirements Specifications (URS), Traceability Matrix, and Validation Summary Reports
• Participate in change control processes and ensure compliance with regulatory requirements
• Provide technical expertise and guidance to project teams regarding validation requirements and best practices
• Perform periodic review and revalidation of systems to ensure continued compliance
• Stay up-to-date with industry trends and regulatory changes related to system validation
• Authors IT validation documents for hardware and software, manages document review and approval workflows
• Performs the analysis of complex business problems and manages business requirements within area of responsibilities
• Performs system administration duties as needed to support the setup and validation of GxP hardware and software
• Experience gathering business requirements, software testing (UAT, IQOQ), creating and writing SOP's and GXP validation documentation
• Experience within CFR Part 11/GxP software qualification
• Understanding of data management for gxp systems
• Implementing and managing data integrity across lab and enterprise systems
• Data resiliency backup, restore, archive
• Audit trails
• Performing annual account reviews, periodic reviews
• Performing GMP data quality assessments and managing deviations
• Managing document review and approval workflows in a global document management system
• Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs)
• Performs the analysis of complex business problems and manages business requirements within area of responsibilities.
• Performs system administration duties as needed to support the setup and validation of GxP hardware and software
• Bachelor's degree in Computer Science, Engineering, or a related field
• Strong understanding of GxP regulations and FDA guidelines, including 21 CFR Part 11
• Experience in designing and executing validation protocols and documentation

Requirements:

• Bachelor's degree in Computer Science, Engineering, or a related field
• Minimum 5 years software and hardware validation experience in a GxP regulated environment
• Strong understanding of GxP regulations and FDA guidelines
• Experience in designing and executing validation protocols
• Excellent communication and interpersonal skills
• Detail-oriented with strong analytical and problem-solving abilities
• Ability to work independently and manage multiple priorities