Validation Specialist

Job Summary:They are interested in temperature mapping experience, specifically CTUs, stability chambers, or similar environments. Strong lab instrument experience.5+ years of hands-on CSV in GxP environments.Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports.Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+.Experience with lab instrument software.Requirements:Experience with CDS, LIMS and major vendor systems.Experience with Computer Software Assurance (CSA) principles.Experience with electronic testing tools (e.g. HPQC/ALM).GAMP or ASQ certifications.Degree in science or engineering.