Calibration Coordinator

Program Management

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 key performance indicators (KPIs) (e.g., completion rates, overdue calibrations, OOT trends).

Regulatory Compliance & Global Standards

Ensure compliance with applicable regulations and standards, including but not limited to: U.S. FDA21 CFR Part 210/211 (cGMP – Pharmaceuticals)21 CFR Part 820 (Quality System Regulation – Medical Devices)European UnionEU GMP (EudraLex Volume 4)Medical Device Regulation (EU MDR 2017/745) and IVDR (as applicable)International StandardsISO 13485 – Medical Device Quality Management SystemsISO 9001 – Quality Management SystemsISO/IEC 17025 – Calibration and Testing Laboratory Competence ICH GuidelinesICH Q7, Q8, Q9, Q10 (Quality Risk Management, Pharmaceutical Quality Systems)Other Regulatory Bodies (as applicable)MHRA (UK), Health Canada, TGA (Australia), PMDA (Japan), etc.

Ensure alignment with data integrity guidance (FDA, MHRA, PIC/S). Maintain continuous inspection readiness for global regulatory inspections and customer audits.

Documentation & Data Integrity

Maintain calibration records, certificates, and traceability per ALCOA+ principles. Ensure calibration standards are traceable to NIST, SI units, or equivalent international standards. Manage calibration data within CMMS and/or validated systems in compliance with:21 CFR Part 11 (Electronic Records/Electronic Signatures)Annex 11 (EU computerized systems)

Review calibration documentation for technical accuracy and regulatory compliance.

Out-of-Tolerance (OOT) Investigations & Quality Systems

Lead or support investigations for calibration failures and out-of-tolerance conditions. Conduct product impact assessments using risk-based methodologies (ICH Q9). Collaborate on CAPA activities to ensure effective root cause resolution and compliance.

Vendor & Laboratory Management

Coordinate external calibration service providers and laboratories. Ensure vendors are qualified per:ISO/IEC 17025 accreditationInternal supplier quality requirements

Review vendor documentation and audit performance where required.

Cross-Functional Collaboration

Partner with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs teams. Support equipment qualification (IQ/OQ/PQ) and lifecycle management. Provide calibration input into risk assessments, URS, and validation protocols.

Continuous Improvement & Global Harmonization

Drive improvements in calibration processes using Lean, Six Sigma, or operational excellence tools. Implement digital solutions and system upgrades (e.g., CMMS, calibration management software).

Qualifications

• High School Diploma or AA Degree at minimum with applicable work experience
• Bachelor’s degree in Engineering, Life Sciences, Metrology, or related technical discipline preferred
• 3–7+ years of calibration, metrology, or maintenance experience in a regulated pharmaceutical, biotech, or medical device environment
• Direct experience supporting global regulatory frameworks and audits
• Strong knowledge of cGMP and global GMP frameworks (FDA, EU, WHO)
• Strong knowledge of calibration principles and metrology best practices
• Strong knowledge of ISO/IEC 17025 laboratory requirements
• Familiarity with CMMS systems (e.g., Master Control, ETQ, SAP PM)
• Familiarity with data integrity principles and electronic systems compliance (Part 11, Annex 11)
• Familiarity with working knowledge of risk management tools and statistical analysis
• Strong organizational and coordination skills across multiple stakeholders
• High attention to detail and compliance mindset
• Strong analytical and problem-solving capabilities
• Global regulatory expertise
• Inspection readiness and audit support
• Data integrity and compliance
• Risk-based decision making
• Continuous improvement mindset