Metrology Coordinator

Metrology Coordinator

The Metrology Coordinator serves as the central planner and administrator for metrology, calibration, and measurement assurance activities across all Kindeva manufacturing plants. The role focuses on organizing, scheduling, tracking, and coordinating all metrology‑related tasks to ensure regulatory compliance (FDA, EMA, GMP), equipment readiness, and minimal operational disruption for aseptic fill‑finish, inspection, assembly, and packaging operations.

• Develop and maintain master calibration and metrology schedules for all critical process, utility, laboratory, and analytical equipment across multiple sites.
• Coordinate 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 such as calibration compliance rates, overdue calibrations, and program metrics.
• Generate monthly/quarterly dashboards and summary reports for site leadership and executive review.
• Assist with basic risk tracking and deviation logging related to metrology events, escalating technical issues to engineers as needed.
• Identify 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).

• 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.

• 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.

California residents should review our Notice for California Employees and Applicants before applying.

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.