Metrology Engineer II

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe Senior Metrology Engineer 2 leads advanced metrology calibration and measurement-system activities supporting pharmaceutical CDMO manufacturing and laboratory operations. The role ensures measurement integrity cGMP and data-integrity compliance program reliability and continuous improvement while providing technical leadership and cross-functional and improve site or multi-site metrology and calibration programs including asset lifecycle management interval optimization and risk-based and oversee calibrations qualifications and measurement system analyses for critical process utility and laboratory review and approve calibration procedures protocols work instructions and technical records in accordance with cGMP and internal quality out-of-tolerance conditions failures and deviations; conduct impact assessments and root-cause analyses; and support CAPA the selection installation qualification and integration of new measurement and laboratory equipment including support for transfers and with Engineering Quality Validation Laboratory Operations Manufacturing and Maintenance to improve measurement capability and equipment calibration-system and CMMS/EAM data schedules history KPIs and data-integrity engineers and technicians review technical work and support training and competency regulatory and customer audits with technical expertise documentation and improvements in measurement uncertainty calibration intervals automation standardization business continuity and QualificationsBachelors degree in Metrology Engineering Physics Chemistry or a related technical field; masters degree preferred.4 years of progressive metrology calibration or measurement-science experience in a regulated cGMP environment including laboratory knowledge of calibration principles measurement uncertainty and traceability to national or international -on experience calibrating process instrumentation and pharmaceutical laboratory with calibration-management systems CMMS/EAM platforms and 21 CFR Part 11 data-integrity knowledge of cGMP quality systems deviations CAPA and change to produce clear technical procedures protocols and investigation analytical root-cause communication collaboration prioritization and technical-leadership QualificationsExperience in aseptic fill-finish sterile manufacturing or CDMO operations and supporting with cleanroom isolator utility and environmental-monitoring with risk-based calibration intervals measurement system analysis reliability engineering or predictive CCT CQE or an equivalent professional with equipment introduction technology or method transfer or multi-site program standardization.