CSV Specialist

Computer System Validation Specialist

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)
• 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.

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 (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.