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 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.
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