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# 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:** October 27, 2026
- **Apply:** https://www.careerjet.com/job/us0eb822680be38eff452747cff04807d3/eaa

## About the Role

* 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).