Metrology Engineer II

About the role

Kindeva makes products that save lives, ensuring better health and well-being for patients around the world. The 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 support.

Responsibilities

• Lead and improve site or multi-site metrology and calibration programs, including asset lifecycle management, interval optimization, and risk-based practices.
• Perform and oversee calibrations, qualifications, and measurement system analyses for critical process, utility, and laboratory instruments.
• Develop, review, and approve calibration procedures, protocols, work instructions, and technical records in accordance with cGMP and internal quality systems.
• Investigate out-of-tolerance conditions, failures, and deviations; conduct impact assessments and root-cause analyses; and support CAPA effectiveness.
• Lead the selection, installation, qualification, and integration of new measurement and laboratory equipment, including support for transfers and start-ups.
• Partner with Engineering, Quality, Validation, Laboratory Operations, Manufacturing, and Maintenance to improve measurement capability and equipment reliability.
• Maintain calibration-system and CMMS/EAM data, schedules, history, KPIs, and data-integrity controls.
• Mentor engineers and technicians, review technical work, and support training and competency development.
• Support regulatory and customer audits with technical expertise, documentation, and responses.
• Drive improvements in measurement uncertainty, calibration intervals, automation, standardization, business continuity, and reliability.

Required Qualifications

• Bachelor's degree in Metrology, Engineering, Physics, Chemistry, or a related technical field; master's degree preferred.
• 4+ years of progressive metrology, calibration, or measurement-science experience in a regulated cGMP environment, including laboratory instruments.
• Strong knowledge of calibration principles, measurement uncertainty, and traceability to national or international standards.
• Hands-on experience calibrating process instrumentation and pharmaceutical laboratory equipment.
• Experience with calibration-management systems, CMMS/EAM platforms, and 21 CFR Part 11 data-integrity requirements.
• Working knowledge of cGMP, quality systems, deviations, CAPA, and change control.
• Ability to produce clear technical procedures, protocols, and investigation reports.
• Strong analytical, root-cause, communication, collaboration, prioritization, and technical-leadership skills.

Preferred Qualifications

• Experience in aseptic fill-finish, sterile manufacturing, or CDMO operations and supporting laboratories.
• Familiarity with cleanroom, isolator, utility, and environmental-monitoring instrumentation.
• Experience with risk-based calibration intervals, measurement system analysis, reliability engineering, or predictive maintenance.
• ASQ CCT, CQE, or an equivalent professional credential.
• Experience with equipment introduction, technology or method transfer, or multi-site program standardization.