Validation Specialist

Job Summary

This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area. This role will be supporting validation leads to help ensure the required deliverables and testing are complete according to the Client CSV SOP. Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel.

Roles & Responsibilities

• Support creation, review, and approval of all CSV deliverables for custom in-house solutions.
• Maintain close communication with stakeholders and team members to keep apprised of CSV needs, interpretation of requirements, impacts on compliance of an application, project status, and other relevant issues.
• Able to create documents to an existing document standard.
• Obtain and respond to review by Business, IT, and Quality stakeholders.
• Follow SOPs and industry best practices.

Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline
• 8-10+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments
• 5+ years of experience in Data Integrity/ALCOA+ principles
• 5+ years of experience with CSA principles
• 5+ years of experience with technical writing
• Firm understanding of technology platforms as needed for project
• Experience with electronic document management systems (e.g. Qumas, SharePoint etc.); application development and lifecycle management (e.g. ALM, Jira, etc.); and IT service management systems (e.g. ServiceNow)
• Excellent oral and written communication skills in English
• Strong expertise and ability to interview and accurately interpret communication requirements of team members
• Familiarity with using AI as an accelerator for creation and review of documents and testing