Metrology Engineer II

Kindeva; Bridgeton, Northern (MO, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Senior Metrology Engineer 2 to lead metrology, calibration, and measurement-system activities across pharmaceutical CDMO operations, ensuring measurement integrity and data quality in regulated environments.

You will manage calibration programs, review procedures, mentor staff, and collaborate with Engineering, Quality, Validation, and Manufacturing to improve equipment reliability and regulatory readiness.

Qualifications

• Bachelor’s degree in Metrology, Engineering, Physics, or related field; master’s degree preferred.
• 4+ years in metrology/calibration in a regulated cGMP environment.
• Strong knowledge of calibration principles, measurement uncertainty, and traceability to standards.
• Hands-on experience calibrating process instrumentation and pharmaceutical laboratory equipment.
• Experience with 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.

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.

Skills

Analytical skills

Root-cause analysis

Communication skills

Leadership

Prioritization

Technical leadership

Education

Bachelor's degree in Metrology, Engineering, Physics, or related

Master's degree preferred

Tools

CMMS/EAM platforms

Calibration-management systems

Job description

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Our Work Matters

The Impact You Will Make

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.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.