Validation Engineer
2 weeks ago
Responsibilities:
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
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