Required:
- Bachelor's degree in Computer Science, Engineering, or a related field
- Minimum of 6 years of business analysis experience and 3 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
- Knowledge of Agile methodologies is a plus
- Minimum of 3 years of experience working as a Business Systems Analyst or Validation Analyst in a GxP regulated environment
- Strong understanding of GxP regulations and FDA guidelines, including 21 CFR Part 11
- Experience in designing and executing validation protocols and documentation
client is looking for a highly skilled Technical Validation Business Systems Analyst to join our team. In this role, you will be responsible for ensuring the compliance and validation of technical systems within our organization.
As a Technical Validation Business Systems Analyst, you will collaborate with cross-functional teams to analyze, validate, and document various IT systems and processes. You will work closely with stakeholders to define requirements, plan and execute validation activities, and ensure that all systems meet regulatory standards. This is an excellent opportunity for someone who is detail-oriented, has a strong understanding of GxP regulations, and is passionate about maintaining compliant systems in a life sciences setting.
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
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Job Duties
- 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 (includes but not limited to User Requirements Specs, System Design Documents, IT System Administration Guides)
- Interface and liaise between IT, Business (all levels of lab staff and management) as well as Third Party vendors
- Create technical system design deliverables (data flow diagrams, network architecture) through independent research and interviews with technical subject matter experts
- Expertise and experience working on and validating a cross section of lab systems (for example, NC-200, XURI (Unicorn), Met One, BACT/MYLA, FACSDiva)
- 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)
- Manage IQOQ and UAT – write and execute test scripts, author test summary reports
- Experience with Agile, Scrum, and Kanban concepts
- Nice to have - experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems
- 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
- Bachelor's degree in Computer Science, Engineering, or a related field