CSV Specialist

Katalyst CRO; Lawrenceville (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks an experienced CSV professional to support enterprise GxP systems in Cell Therapy projects. You will assist validation leads, ensure deliverables and testing align with the Client CSV SOP, and communicate with Business, IT, and Quality teams.

The role requires extensive pharma/biotech validation experience, strong data integrity, CSA principles, and proficiency with Qumas, SharePoint, ALM/Jira, and EDMS.

Qualifications

• 8–10+ years in pharmaceutical/biotech or regulated environments.
• 5+ years applying Data Integrity/ALCOA+ in CSV contexts.
• Strong understanding of CSA principles and regulatory expectations.
• Experience with regulatory writing and document control.
• Familiarity with GMP, GLP and GAMP5 principles.
• Ability to develop, review, and approve CSV deliverables.

Responsibilities

• Support creation, review, and approval of CSV deliverables for custom in-house solutions.
• Maintain communication with stakeholders to track CSV needs and compliance.
• Create documents to established standards and respond to reviews.
• Follow SOPs and industry best practices in validation activities.
• Leverage tools like EDMS, Qumas, SharePoint, ALM/Jira for documentation and lifecycle management.

Skills

Data Integrity/ALCOA+

CSA principles

Technical writing

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Pharma/related

Tools

MS Office

Visio

Qumas

SharePoint

ALM

Jira

ServiceNow

EDMS

Job description

• 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
• 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.