Calibration Coordinator

Burke Porter, an Ascential Technologies Brand•Andover, MN

About The Position

The Calibration Coordinator administers and maintains the calibration program to support compliance with U.S. FDA regulations, international regulatory requirements, and industry standards. The role supports product quality, data integrity, and inspection readiness across multiple regulatory jurisdictions by ensuring instruments and systems are calibrated, documented, and controlled in accordance with global GMP and quality system expectations. The Coordinator manages calibration activities for manufacturing, laboratory, and facility equipment; maintains risk-based schedules; monitors program performance; and oversees calibration documentation, traceability, and data in CMMS or other validated systems. The role also supports out-of-tolerance investigations, product impact assessments, CAPA, deviations, change control, and nonconformance processes. The position coordinates external calibration providers and laboratories, collaborates with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs, and supports equipment qualification and lifecycle management. It also contributes to process improvement, digital solutions, and global harmonization. Duties are performed in office and GMP-regulated production or laboratory environments, following company quality and safety standards.

Requirements

High school diploma or associate degree at minimum, with applicable work experience.
3–7+ years of calibration, metrology, or maintenance experience in a regulated pharmaceutical, biotechnology, or medical device environment.
Direct experience supporting global regulatory frameworks and audits.
Strong knowledge of cGMP and global GMP frameworks, including FDA, EU, and WHO requirements.
Strong knowledge of calibration principles and metrology best practices.
Strong knowledge of ISO/IEC 17025 laboratory requirements.
Familiarity with CMMS systems, such as MasterControl, ETQ, or SAP PM.
Familiarity with data integrity principles and electronic systems compliance, including 21 CFR Part 11 and Annex 11.
Working familiarity with risk management tools and statistical analysis.
Strong organizational and coordination skills across multiple stakeholders.
High attention to detail and a compliance mindset.
Ability to communicate effectively in a cross-functional environment.
Strong analytical and problem-solving capabilities.
Ability to lift, carry, or move up to 50 pounds and stand for extended periods.
Ability to wear required PPE and work safely independently and around others by following required procedures.

Nice To Haves

Bachelor’s degree in Engineering, Life Sciences, Metrology, or a related technical discipline.
Experience driving continuous improvement using Lean, Six Sigma, or operational excellence tools.

Responsibilities

Coordinate and manage the calibration program for manufacturing, laboratory, and facility equipment.
Maintain calibration schedules aligned with regulatory requirements and risk-based methodologies.
Track and report program KPIs, including completion rates, overdue calibrations, and out-of-tolerance trends.
Ensure alignment with applicable U.S., European, and international regulations, standards, and data integrity guidance.
Maintain continuous inspection readiness for global regulatory inspections and customer audits.
Maintain calibration records, certificates, and traceability in accordance with ALCOA+ principles and applicable standards.
Ensure calibration standards are traceable to NIST, SI units, or equivalent international standards.
Manage calibration data in CMMS and/or validated systems in compliance with 21 CFR Part 11 and EU Annex 11.
Review calibration documentation for technical accuracy and regulatory compliance.
Lead or support investigations of calibration failures and out-of-tolerance conditions.
Conduct product impact assessments using risk-based methodologies and collaborate on CAPA and root-cause resolution.
Support deviation, change control, and nonconformance processes.
Coordinate external calibration service providers and laboratories; ensure vendor qualification and review vendor documentation and performance.
Partner with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs teams.
Support equipment qualification (IQ/OQ/PQ) and lifecycle management.
Provide calibration input to risk assessments, user requirements specifications, and validation protocols.
Improve calibration processes using Lean, Six Sigma, or operational excellence tools.
Implement digital solutions and system upgrades, such as CMMS and calibration management software.
Follow company quality, safety, and attendance policies; participate in team building, training, and department communications; perform additional responsibilities as assigned.