CSV Specialist

About the role

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. The incumbent will support validation leads to ensure required deliverables and testing are completed according to the client CSV SOP. Effective communication across a multi‑functional team of Business, IT, and Quality personnel is essential. Experience with current digital validation tools is required; use of 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 conform to existing document standards.
• Obtain and respond to reviews by Business, IT, and Quality stakeholders.
• Follow SOPs and industry best practices.
• Utilize advanced knowledge of the complete MS Office suite and Visio.
• Apply firm understanding of technology platforms as needed for the project.
• Work with electronic document management systems (e.g., Qumas, SharePoint) and application development/lifecycle management tools (e.g., ALM, Jira).
• Interact with IT service management systems (e.g., ServiceNow).
• Demonstrate excellent oral and written communication skills in English.
• Interview and accurately interpret communication requirements of team members.
• Leverage AI as an accelerator for creation and review of documents and testing.

Requirements

• 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, including written and verbal communication.
• Strong sense of ethics, diplomacy, and discretion.
• Commitment to quality and 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 and ability to manage competing priorities.