CSV Consultant

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).