Data Analyst

Role Overview

This role will focus on Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area. The role will support validation leads to ensure required deliverables and testing are complete according to the client CSV SOP. Effective communication is key across a multi‑functional team.

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.

A solid CSV background and having a strong work ethic in an aggressive project setting will be key to being successful in this role. Experience with current digital validation tools is required; use of AI as an accelerator is a plus.

• 7+ years of experience in project management, commercial operations, or launch operations within the pharmaceutical or biotech industry
• Proven track record managing complex, multi‑workstream programs in a senior capacity
• Strong experience building and maintaining PM documentation
• Experience with metrics and data reporting, including presenting insights to senior stakeholders
• Excellent written and verbal communication skills
• Exceptional collaboration skills
• Full training on Lx systems and tools will be provided
• 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, 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

Full training on Lx systems and tools will be provided.

Equal opportunity employer.