CSV Consultant New York • Full time

Learn Gmp; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Learn GMP seeks a CSV Consultant in New York to lead end‑to‑end validation of GxP computer systems (ERP/LIMS/MES/QMS/IT infra). You will craft critical validation deliverables and advise on FDA 21 CFR Part 11, EU Annex 11, and data integrity.

You will interact with clients, manage multiple projects, and contribute to audits, remediation, and knowledge transfer while staying current with regulatory changes.

Qualifications

• 3–7 years of direct CSV experience in regulated life sciences.
• Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ Data Integrity.
• Experience writing and executing the full suite of validation documentation.
• Experience with LIMS, QMS, ERP and various SDLC/methodologies (Waterfall, V‑Model, Agile).

Responsibilities

• Lead and execute CSV projects across validation lifecycles for GxP systems.
• Develop and review Validation Plans, URS, FS, DS, IQ/OQ/PQ, and reports.
• Provide regulatory expertise on Part 11, data integrity, and predicate rules.
• Apply risk-based validation per GAMP 5 to match system risk and complexity.
• Serve as primary CSV SME for clients, managing stakeholder communication.
• Support audits/inspections, including preparation and response to findings.
• Lead remediation efforts and validate legacy systems.
• Provide training to staff and junior consultants on CSV practices.
• Stay current with evolving global regulations and digital validation trends.

Skills

CSV project leadership

Regulatory compliance

Analytical/problem-solving

Technical writing

Client communication

Time management

Education

Bachelor’s or Master’s degree in IT/Life Sciences

Tools

Documentation tools

Document management systems

Job description

# CSV ConsultantNew York • Full timeKey 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).### Apply for this position