GxP Systems Engineer
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GxP Systems Engineer (Contract)Location: Norwood, MA (Onsite / Hybrid)Job Type: ContractIndustry: Biopharmaceutical / Life SciencesWhat You’ll Be DoingIn this role, you will bridge the gap between QC labs, Digital teams, and Automation Engineers to ensure compliant and scalable operations across connected platforms:System Design & Deployment: Configure and support Digital Quality Automation systems and analytical laboratory instrumentation in GMP-regulated environments.Integrations & Connectivity: Connect lab instruments and systems (e.g., Hamilton Venus, Scitara DLX) with enterprise cloud/SaaS platforms and on-prem infrastructure.Validation & Compliance: Lead Computer System Validation (CSV) activities (IQ/OQ/PQ) ensuring compliance with GxP, GAMP5, Data Integrity, and 21 CFR Part 11.Lifecycle & Documentation: Oversee change controls, SOPs, work instructions, system upgrades, and maintain continuous inspection readiness for audits.Innovation: Collaborate on robotics platforms, automation initiatives, and AI-driven digital workflows in QC lab settings.What We’re Looking For🎓 Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.⌛ Experience: 5+ years supporting lab automation platforms, analytical instruments, or lab systems in a GMP biopharma environment.🛠️ Core Expertise:Hands-on experience with automation platforms (e.g., Hamilton Venus).Strong mastery of GxP/GMP, GAMP5, CSV, and Data Integrity standards.Experience with cloud/SaaS connectivity and on-prem infrastructure integration.Sharp troubleshooting and analytical skills in fast-paced lab settings.Nice-to-Haves / PreferredExperience with Scitara DLX or similar laboratory integration middleware.Knowledge of LIMS, ELN, and instrument connectivity tools.Basic familiarity with Linux/Ubuntu command-line/system administration.Prior involvement in FDA or regulatory audit proceedings.Tech Stack / Key SkillsGxP/GMP • GAMP5 • CSV (IQ/OQ/PQ) • Hamilton Venus • Scitara DLX • 21 CFR Part 11 • Data Integrity • Lab Automation • QC Lab Systems • Linux/UbuntuChandan SinghTechnical RecruiterGlobal Applications Solution LLC (USA)📞 USA: +1 201-499-7364 | 📱 WhatsApp: +91 9045934500📧 chandan.s@globalapplications.com