Validation Engineering

Computer System Validation Specialist

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. Experience with current digital validation tools is required, use of AI as an accelerator is a plus. Overall a solid CSV background and having a strong work ethic in an aggressive project setting will be key to being successful in this role.

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. Ability to create documents to an existing document standard. Obtain and respond to review by Business, IT, and Quality stakeholders. Advanced knowledge of complete MS Office suite and Visio. 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. and IT service management systems (e.g. ServiceNow). Excellent oral and written communication skills in English. Familiarity with using AI as an accelerator for creation and review of documents and testing.

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 technical writing. Validation protocols and reports, Risk assessments (FMEA, impact assessments), SOPs, deviation investigations, and CAPAs. Ability to support regulatory inspections and audits (FDA, EMA, internal, or client audits). Strong technical writing skills with attention to detail and data integrity. Proficiency with common pharmaceutical documentation systems and tools (e.g., Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights. Commitment to Quality.