> Markdown version of [/jobs/ext/212792-csv-specialist](https://www.wearedevelopers.com/jobs/ext/212792-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:** Harrisburg, PA, 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=84c4841411f365ef ## About the Role Do you have experience in Test validation method?, * 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. * 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). ## 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) - [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) - [Applying Agile Principles to Incident Management ](https://www.wearedevelopers.com/videos/101-applying-agile-principles-to-incident-management) - [AIQSpecFlow: Improves and automates your agile process of specification and creation of testcases.](https://www.wearedevelopers.com/videos/100084-aiqspecflow-improves-and-automates-your-agile-process-of-specification-and-creation-of-testcases) - [Hiring AI Native Talents](https://www.wearedevelopers.com/videos/100268-hiring-ai-native-talents) - [AI in Production: applied AI & enterprise use cases](https://www.wearedevelopers.com/videos/100130-ai-in-production-applied-ai-enterprise-use-cases) ## Related Articles - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Starter Kit For Job Applications For Developers](https://www.wearedevelopers.com/magazine/7-starter-kit-for-job-applications-for-developers) - [Quick guide: How to write a Software Developer CV](https://www.wearedevelopers.com/magazine/37-quick-guide-how-to-write-a-software-developer-cv) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated) - [Dev Digest 121 - AI goes offline](https://www.wearedevelopers.com/magazine/456-dev-digest-121-ai-goes-offline) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs)