CSV 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.

Do you have experience in Validation design?, * 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., * 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.