ppAs Metrology Manager at Sanofi's Goa GMP site, you lead the site-wide metrology and calibration program to ensure instruments stay accurate, traceable and compliant. You will collaborate with Engineering, Quality, Validation and Manufacturing to maintain calibration readiness and drive continuous improvements. You'll manage external calibration partners and coordinate with NABL labs to uphold GMP data integrity. This role offers exposure to regulatory inspections, equipment qualification and cross-functional problem solving. You will shape metrology practices that support product quality and patient safety. /pulliLead the site-wide metrology and calibration program for measuring and test equipment /liliPlan, schedule and coordinate calibration activities to ensure timely completion and compliance /liliManage calibration of critical process and analytical instruments (temperature, pressure, flow, pH, conductivity, weighing) /liliDefine and review calibration frequencies and acceptance criteria based on equipment criticality /liliMaintain audit-ready calibration records in CMMS/SAP and ensure GMP/data integrity compliance /liliCoordinate with NABL-accredited calibration service providers; review certificates and ensure traceability /liliSupport qualification, evaluation and periodic review of external calibration providers /liliEnsure metrology activities comply with cGMP/GxP/GDP and regulatory requirements; maintain audit readiness /liliSupport regulator and internal audits; lead or support deviation investigations and CAPA related to measurement systems /liliParticipate in Change Control for equipment/measurement system modifications; support QA in CAPA closure /liliProvide metrology input for IQ/OQ/PQ,
equipment qualification and requalification /liliSupport preventive maintenance and troubleshooting to improve reliability and minimize downtime /liliDevelop and update SOPs, training and drive continuous improvement in metrology processes /liliCoach and develop metrology staff to ensure GMP/HSE compliance and engineering competencies /liliEngage with cross-functional teams to ensure timely implementation of corrective and preventive actions /liliContribute to metrology-related decisions in deviations, OOT investigations, and external vendor management /liliEnsure safety and site procedures alignment across all metrology activities /liliBachelor's degree in Electrical Electronics Engineering with 5+ years of metrology management in pharma OR Diploma in Electrical Electronics Engineering with 10+ years in pharma metrology management /liliStrong hands-on experience in GMP manufacturing metrology and calibration /liliExperience managing a site-wide calibration/metrology program (preferred) /liliKnowledge of metrology principles and calibration practices for temperature, pressure, flow, pH, conductivity and weighing systems /liliExperience with IQ/OQ/PQ and equipment qualification/requalification; temperature mapping knowledge /liliExperience with NABL-accredited labs/service providers and ensuring traceability to standards /liliProficiency in SAP or other CMMS systems /liliUnderstanding of cGMP/GxP, data integrity and regulatory inspections; supporting audits /liliStrong communication, analytical, problem-solving and stakeholder management skills /liliAbility to collaborate with Engineering, Quality, Validation and Manufacturing teams /liliAnalytical and problem-solving abilities /liliMetrology principles and calibration practices /liliTemperature, pressure, flow, pH, conductivity and weighing systems /liliIQ/OQ/PQ and equipment qualification/requalification /li /ulpMetrology Manager napoli, campania, it /p /p #J-18808-Ljbffr
📌 Metrology Manager (Napoli)
🏢 Sanofi
📍 Napoli