Metrology Coordinator
Kindeva Drug Delivery · St. Louis County, MO · 3 wk ago
On-siteOTHRFull-time
Key Responsibilities
- Develop and maintain master calibration and metrology schedules for all critical process, utility, laboratory, and analytical equipment across multiple sites.
- Cook up calibration timelines with manufacturing operations, maintenance teams, and project schedules to minimize production impact.
- Create and update annual/quarterly metrology plans, incorporating new equipment onboarding, shutdown windows, and technology transfer activities.
- Serve as the central coordinator between internal site teams, external calibration vendors, and service providers to ensure timely scheduling and execution of calibration, verification, and qualification activities.
- Track vendor performance, purchase orders, service contracts, and invoices related to metrology services.
- Facilitate cross-site communication for shared resources, equipment movement, and standardization of procedures.
- Maintain accurate and compliant metrology documentation, including calibration records, certificates, equipment hierarchies, and historical data in the CMMS (e.g., LLumin or equivalent).
- Ensure all records meet data integrity requirements (ALCOA+) and are audit-ready.
- Manage metrology databases, calibration due-date tracking, and overdue item escalations.
- Support regulatory inspections, internal audits, and client audits by preparing metrology documentation and status reports.
- Track and report key performance indicators (KPIs) such as calibration compliance rates, overdue calibrations, and program metrics.
- Generate monthly/quarterly dashboards and summary reports for site leadership and executive review.
- Aid in identifying opportunities to improve planning processes, automate scheduling/tracking, and enhance standardization across plants.
- Organize and maintain training records, SOPs, and metrology-related administrative files.
- Support capital projects, facility expansions, and new line qualifications through metrology planning and coordination activities.
- Handle general administrative tasks such as budgeting inputs for metrology services, spare parts inventory tracking, and travel coordination for vendor visits (estimated 15-25% travel).
Qualifications & Requirements
- Bachelor’s degree in Business Administration, Engineering, Life Sciences, or a related field (or equivalent combination of education and experience).
- 4+ years of experience in planning, coordination, or administrative roles in a regulated pharmaceutical, biotechnology, or manufacturing environment (CDMO experience preferred).
- Strong background in scheduling, vendor coordination, and compliance documentation management.
- Familiarity with CMMS systems (LLumin preferred), calibration tracking tools, and basic metrology concepts.
- Excellent organizational, planning, and time-management skills with the ability to manage multiple priorities across sites.
- Strong attention to detail and proficiency in maintaining compliant documentation.
- Proficient in Microsoft Office Suite (especially Excel for scheduling and reporting) and data visualization tools.
- Solid understanding of GMP regulations and basic compliance requirements in pharmaceutical manufacturing.
- Effective communication and coordination skills; ability to work collaboratively in a matrix, multi-site environment.
- Project coordination experience and problem-solving mindset for administrative and logistical challenges.
Preferred Qualifications
- Experience supporting metrology or maintenance planning in aseptic manufacturing or fill-finish environments.
- Certification in project management (PMP), planning, or administrative processes.
- Familiarity with reliability programs, equipment qualification (IQ/OQ/PQ), or Lean/Six Sigma principles.
- Previous exposure to multi-plant operations in a CDMO setting.