Senior CSV Engineer – Analytical Systems & Software Validation

Job Title: Senior CSV Engineer Analytical Systems & Software ValidationPosition OverviewWe are seeking a Senior Computer Systems Validation (CSV) Engineer specializing in the qualification and validation of laboratory analytical equipment and its associated software. In this role, you will ensure that all computerized analytical systems comply with global regulatory standards (FDA, EMA) and internal quality guidelines. Experience in Advanced Therapy Medicinal Products (ATMPs), specifically Cell and Gene Therapy (CGT) environments, is highly preferred.Key ResponsibilitiesSoftware Qualification: Lead and execute lifecycle validation (GxP) for laboratory analytical equipment and integrated software systems (e.g., Chromatography Data Systems, LIMS, spectrophotometers, qPCR software).Validation Lifecycle Management: Draft, review, and execute lifecycle documentation including Validation Plans, User Requirement Specifications (URS), Risk Assessments (FMEA), Functional Specifications, IQ/OQ/PQ protocols, and Validation Summary Reports.Regulatory & Data Integrity Compliance: Ensure all standalone and networked analytical systems strictly comply with FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ Data Integrity principles.Audit Readiness: Serve as the subject matter expert (SME) for computerized analytical software during internal audits and regulatory inspections.Vendor Management: Collaborate with laboratory equipment vendors to review technical specifications, software patches, and factory/site acceptance testing (FAT/SAT) documentation.Deviation & CAPA Handling: Investigate validation deviations, author comprehensive non-conformance reports, and implement robust Corrective and Preventive Actions (CAPAs).Required Qualifications & ExperienceEducation: Bachelor s degree in Life Sciences, Bioengineering, Computer Science, or a related technical field.Experience: Minimum of 5 8 years of direct Computer Systems Validation (CSV) experience within the pharmaceutical or biotech industry.Technical Expertise: Proven track record validating analytical equipment software (e.g., Empower, LabVantage, SoftMax Pro, or instrument-specific control software).Regulations: Deep knowledge of GAMP5, FDA 21 CFR Part 11, Annex 11, and current Data Integrity guidance.Preferred QualificationsCell & Gene Therapy (CGT): Direct validation experience within a Cell or Gene therapy manufacturing facility or specialized ATMP QC laboratory.Agile Environments: Experience handling rapid-turnaround validation cycles typical for personalized medicine workflows.