Metrology Manager Kindeva Drug Delivery Careers - 2.1 St. Louis, MO Job Details Full-time 20 hours ago Qualifications Incident investigation techniques for hazard identification Pharmaceutical regulatory compliance Preventive action implementation Production deviation management Corrective and preventive actions (CAPA)

FDA 21 CFR

Part 11 GMP Internal investigations Laboratory equipment calibration Team development Data integrity and documentation Managing engineering teams Laboratory regulatory affairs Maintenance records management Meter maintenance Laboratory quality control Laboratory budgeting Project stakeholder communication Cross-functional communication Audit support Pharmaceutical manufacturing facility experience Facilities budget management Stakeholder management Measurement (quality control) Full Job Description 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 c

GMP, 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. California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

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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. Do you see yourself as part of the Kindeva mission? Click Today!