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GMP Career Opportunity

CSV Consultant

📍 New York 💼 Full time

We are seeking a highly skilled and experienced CSV Consultant to join our dynamic team. You will be responsible for providing expert guidance and hands-on execution of Computer System Validation activities for our clients' regulated systems (GxP: GMP, GLP, GCP). The ideal candidate will have a deep understanding of regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines) and a proven track record of delivering successful validation projects from inception to completion.

Position Overview

Industry
GMP / Pharma
Department
Validation
Work Type
Full time
Location
New York

Job Description

  • Key Responsibilities: Lead and Execute CSV Projects: Manage and perform all phases of the validation lifecycle for GxP computer systems (e.g., ERP, LIMS, MES, QMS, Clinical Systems, IT Infrastructure).
  • Develop Documentation: Author, review, and approve key validation deliverables including Validation Plans, Risk Assessments (GxP, Part 11), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Configuration Specifications, Test Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
  • Provide Regulatory Expertise: Advise clients on compliance with FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, Data Integrity, and relevant predicate rules.
  • Risk Management: Apply risk-based validation methodologies per GAMP 5 guidelines to ensure efforts are proportionate to system risk and complexity.
  • Client Interaction & Liaison: Serve as the primary CSV subject matter expert for clients, managing stakeholder communication, translating business needs into validation requirements, and presenting validation strategies and outcomes.
  • Audit Support: Support internal and external regulatory audits/inspections, including preparation, hosting, and responding to findings related to computer systems.
  • Remediation & Legacy Systems: Lead or support validation remediation projects and the qualification of legacy systems.
  • Training & Mentorship: Provide training and guidance to client staff and junior consultants on CSV principles and practices.
  • Stay Current: Maintain up-to-date knowledge of evolving global regulations, industry standards, and best practices in CSV and digital technology (e.g., Cloud/SaaS validation, Agile validation).
  • Required Qualifications & Skills: Bachelor’s or Master’s degree in Computer Science, Information Technology, Life Sciences, Engineering, or a related field.
  • Minimum of [e.g., 3-5, 5-7] years of direct, hands-on CSV experience in a regulated life sciences environment (Pharma, Biotech, Med Device, CRO).
  • In-depth, practical knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity (ALCOA+) requirements.
  • Proven experience writing and executing the full suite of validation documentation.
  • Experience with a variety of GxP systems (LIMS, QMS, ERP, etc.) and software development methodologies (Waterfall, V-Model, Agile/Scrum).
  • Strong understanding of software development lifecycle (SDLC) and IT infrastructure qualification.
  • Excellent analytical, problem-solving, and technical writing skills.
  • Outstanding communication and interpersonal skills, with the ability to explain complex concepts to non-technical stakeholders.
  • Ability to manage multiple projects concurrently, work independently, and thrive in a client-facing consulting role.
  • Willingness to travel to client sites as needed (if applicable).
  • Preferred Qualifications: Relevant professional certifications (e.g., ASQ CSQE, ISTQB).
  • Experience with Cloud-based/SaaS platform validation.
  • Knowledge of medical device standards (ISO 13485, IEC 62304).
  • Experience in a consulting or service provider role.
  • Project management experience or certification (PMP, PRINCE2).
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