CSV Specialist

Role Overview

This role focuses on Computer System Validation (CSV) activities for enterprise GxP systems, specifically supporting critical projects in the Cell Therapy functional area. The incumbent will assist validation leads to ensure deliverables and testing are completed according to the client CSV SOP. Effective communication across Business, IT, and Quality teams is essential. Experience with current digital validation tools is required; familiarity with AI as an accelerator is a plus. A solid CSV background and a strong work ethic in an aggressive project setting are key to success.

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 them apprised of CSV needs, interpretation of requirements, compliance impacts, project status, and other relevant issues.
• Create documents that adhere to existing document standards.
• Obtain and respond to reviews by Business, IT, and Quality stakeholders.
• Follow SOPs and industry best practices.
• Advanced knowledge of the complete Microsoft Office suite and Visio.
• Firm understanding of technology platforms as needed for the project.
• Experience with electronic document management systems (e.g., Qumas, SharePoint), application development and lifecycle management tools (e.g., ALM, Jira), and IT service management systems (e.g., ServiceNow).
• Excellent oral and written communication skills in English.
• Strong expertise in interviewing and accurately interpreting communication requirements of team members.
• Familiarity with using AI as an accelerator for creation and review of documents and testing.

Qualifications

• 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 (e.g., Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT) is desired.
• Ability to provide innovative ideas to improve quality and compliance, including seeking new information and external insights.
• Excellent interpersonal skills, both written and verbal.
• Strong sense of ethics, diplomacy, and discretion.
• Commitment to quality.
• Strong critical‑thinking ability to analyze complex situations and discern critical issues.
• Ability to work effectively with a highly matrixed, multicultural workforce and build strong relationships through transparency, reliability, and delivering on commitments.
• Excellent team‑player attitude.
• Ability to manage competing priorities.