Job Description
The Validation Specialist provides expertise for the implementation, modification, and decommissioning of regulated laboratory equipment and computerized laboratory systems, including complex Excel spreadsheets. The role ensures full compliance with internal procedures and industry best practices (21 CFR Part 11, GAMP5, NIST, GCLP, GLP, etc.). The incumbent evaluates, plans, and coordinates project resources, analyzes user needs, and oversees the documentation, testing, and maintenance of laboratory equipment and computerized systems.
Key Responsibilities
Lead multiple validation projects simultaneously and ensure timely delivery in collaboration with internal and external stakeholders (laboratory teams, QA, IT, scientists, vendors).
Write, review, and approve validation deliverables, including validation plans and reports, user requirements, functional specifications, risk assessments, design specifications,...