Global Calibration & Compliance Specialist

Burke Porter, an Ascential Technologies Brand; Ham Lake (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

Burke Porter, an Ascential Technologies Brand, seeks a Calibration Coordinator to manage the calibration program and ensure FDA/EU/ISO compliance. You will support product quality, data integrity, and audit readiness through proper calibration and documentation.

The role requires 3–7+ years in calibration/metrology within regulated environments, knowledge of cGMP and Part 11, CMMS familiarity, and strong cross-functional collaboration with Engineering, Manufacturing, Quality, and Validation.

Qualifications

• Bachelor’s degree in Engineering or related field; 3–7+ years calibration/metrology in regulated environment.
• Strong knowledge of cGMP and global GMP frameworks (FDA, EU, WHO).
• Familiarity with CMMS systems and electronic records (Part 11/Annex 11).

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 KPIs (e.g., completion rates, overdue calibrations, OOT trends).
• Lead or support investigations for calibration failures and CAPA activities.
• Coordinate external calibration service providers and laboratories.
• Collaborate with Engineering, Manufacturing, Quality, Validation, and Regulatory teams.

Skills

Regulatory compliance

Calibration management

Quality systems

Risk management

Data integrity

Cross-functional collaboration

GMP knowledge

Documentation control

Education

Bachelor's degree in Engineering or related field

Tools

CMMS (Master Control/ETQ/SAP PM)

Job description

Burke Porter, an Ascential Technologies Brand, seeks a Calibration Coordinator to manage the calibration program and ensure FDA/EU/ISO compliance. You will support product quality, data integrity, and audit readiness through proper calibration and documentation.

The role requires 3–7+ years in calibration/metrology within regulated environments, knowledge of cGMP and Part 11, CMMS familiarity, and strong cross-functional collaboration with Engineering, Manufacturing, Quality, and Validation.