> Markdown version of [/jobs/ext/243338-csv-specialist](https://www.wearedevelopers.com/jobs/ext/243338-csv-specialist). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # CSV Specialist - **Company:** Katalyst Talent Agency - **Location:** Rochester, NY, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, JIRA, Data Integrity, Document Management Systems, Enterprise Document Management System, Failure Mode Effects Analysis, Microsoft Office, Microsoft Visio, Microsoft SharePoint, Software Engineering, System Testing, GXP, Servicenow - **Published:** May 23, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=31a7a0d9a7fbfe8b ## About the Role Do you have experience in Validation design?, * 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., * 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 * Working knowledge of GMP, GLP, and GAMP 5 principles * Strong understanding of FDA regulations, ICH guidelines, and EU Annex 11 (as applicable) * Experience developing, executing, and reviewing: + 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., EDMS, change control systems) * Excellent organizational, communication, and cross functional collaboration skills * Cross-functional experience in one or more regulated areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired. * Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights. * Excellent interpersonal skills, including written and verbal communication. * Strong sense of ethics, diplomacy and discretion. * Commitment to Quality. * Strong critical thinking to analyze complex situations and discern critical issues. * Able to work effectively with highly matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable and delivering on commitments. * Excellent team player attitude. * Ability to manage competing priorities. ## Description * 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. 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 * Ability 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 * Advanced knowledge of complete MS Office suite and Visio. * Firm understanding of technology platforms as needed for project. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Applying Agile Principles to Incident Management ](https://www.wearedevelopers.com/videos/101-applying-agile-principles-to-incident-management) - [Improving quality with Agentic AI with Rovo Dev and Xray](https://www.wearedevelopers.com/videos/2005-improving-quality-with-agentic-ai-with-rovo-dev-and-xray) - [Robots are coming into the wild! 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