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Open nowPosted 46 days ago

Metrology Manager

kindeva78 open roles

Where
St. Louis, MO, USA
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Your applicationOpen nowMetrology Managerkindeva · St. Louis, MO, USA

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  5. 33.7%30 days
This job: posted 46 days ago

The posting

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Manager of Metrology leads the site or multi-site calibration program supporting pharmaceutical CDMO manufacturing and laboratory operations. This role ensures measurement integrity, cGMP compliance, data integrity, operational reliability, and continuous improvement through technical direction, people leadership, and cross-functional collaboration. Essential Functions

Own metrology strategy, governance, resource planning, priorities, and the multi-year roadmap for process, utility, and laboratory instrumentation. Build and develop a high-performing team of engineers and technicians through coaching, performance management, competency development, succession planning, and effective resource allocation. Ensure compliance with cGMP, 21 CFR Part 11, and internal quality requirements, including competence, traceability, measurement uncertainty, technical records, and data integrity. Oversee calibration execution, method development and validation, uncertainty evaluation, equipment control, and nonconforming work for manufacturing and laboratory instruments. Lead investigations, impact assessments, and CAPAs for out-of-tolerance events, measurement failures, and system nonconformances. Partner with Engineering, Quality, Validation, Laboratory Operations, Maintenance, and site leadership to align metrology with reliability, process capability, analytical performance, and business priorities. Own calibration-system configuration, asset hierarchy, scheduling, data controls, KPIs, and reporting across manufacturing and laboratory assets. Lead audit readiness and serve as the primary metrology representative for regulatory and customer audits. Manage the metrology budget, headcount, external services, standards, equipment, and improvement investments. Improve and standardize calibration intervals, methods, automation, uncertainty, proficiency testing, and multi-site practices. Support business continuity, capital projects, and new equipment or technology introductions while promoting technical excellence and right-first-time execution.

    Required Qualifications

Bachelor’s degree in metrology, engineering, physics, chemistry, or a related technical field; master’s preferred. 8+ years of progressive metrology, calibration, or measurement-science experience in a regulated cGMP environment, including laboratory calibration. 2+ years leading engineers or technicians, with demonstrated team-development and performance-management results. Practical expertise in measurement uncertainty, metrological traceability, calibration-program governance, and audit support. Hands-on experience with process instrumentation and pharmaceutical laboratory equipment, such as balances, pipettes, volumetric systems, environmental chambers, and analytical instruments. Experience with calibration management, CMMS, or EAM systems and electronic-record controls under 21 CFR Part 11. Demonstrated ability to lead investigations and CAPAs, influence stakeholders, manage budgets and resources, and communicate clearly.

  Preferred Qualifications

Experience in aseptic fill-finish, sterile manufacturing, CDMO operations, or supporting QC and analytical laboratories. Leadership or system-owner experience in a regulated calibration laboratory, including audit support. Experience with reliability engineering, asset management, predictive maintenance, Lean or continuous improvement, or multi-site standardization. Professional credentials such as ASQ CCT or CQE, Six Sigma certification, or equivalent training. Experience supporting capital projects, technology transfers, or new facility and production-line start-ups.

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