Validation Specialist

Katalyst CRO; Lawrenceville (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced professional focusing on Computer System Validation (CSV) for critical projects in the Cell Therapy area. This role requires excellent communication across teams and proficiency with digital validation tools.

The ideal candidate should have at least 8-10 years of experience in regulated environments and a Bachelor's degree in a related field, along with a proven track record in technical writing and compliance with regulations.

Qualifications

• 8-10+ years in pharmaceutical, biotechnology, or regulated manufacturing environments.
• 5+ years in Data Integrity/ALCOA+ principles.
• Strong understanding of FDA regulations and ICH guidelines.

Responsibilities

• Support creation, review, and approval of all CSV deliverables.
• Maintain communication with stakeholders about CSV needs.
• Create documents to standard and follow SOPs.

Skills

Effective communication

Technical writing

Data Integrity/ALCOA+ principles

Cross-functional collaboration

Critical thinking

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or related

Tools

MS Office Suite

Visio

Jira

ServiceNow

Qumas

SharePoint

Job description

Job Summary

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. It supports validation leads to ensure required deliverables and testing are complete per 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, with AI as an accelerator considered a plus. A solid CSV background and strong work ethic in an aggressive project setting will be key to success.

Roles & 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, impacts on compliance of an application, project status, and other relevant issues.
• Create documents to an existing document standard.
• Obtain and respond to reviews by Business, IT, and Quality stakeholders.
• Follow SOPs and industry best practices.
• Possess advanced knowledge of the complete MS Office suite and Visio.
• Have a firm understanding of technology platforms as needed for the project.
• Use electronic document management systems (e.g., Qumas, SharePoint); application development and lifecycle management (e.g., ALM, Jira); and IT service management systems (e.g., ServiceNow).
• Exhibit excellent oral and written communication skills in English; interview and accurately interpret communication requirements of team members.
• Familiarity with using AI as an accelerator for creation and review of documents and testing.

Education & Experience

• 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, creating 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 a 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.