Calibration Manager (GMP) — Flexible, Remote Options

Chiesi Group; Lombardia; On-site; EUR 47,000 - 57,000; Full time

Benefits offered by this job

Annual bonus scheme

Comprehensive benefits package (pensi͏

Job summary

Chiesi Group in Nerviano, Milan, is seeking a Calibration Manager to lead the calibration program for utilities and process equipment across the site, ensuring GMP compliance and data integrity while collaborating with engineering, manufacturing, QA, Validation and Maintenance.

You will develop the calibration master plan, manage records and documentation, coordinate internal and external resources, support qualification and commissioning of new equipment, and drive continuous improvement

Qualifications

• Degree in Engineering or a related scientific discipline or technical diploma.
• Minimum 5 years of experience in calibration, maintenance, engineering, or technical services within GMP-regulated industry.
• Strong knowledge of calibration principles for process instrumentation and utility systems.
• Experience with GMP regulations, Data Integrity principles, and pharmaceutical quality systems.
• Knowledge of utilities such as HVAC, Purified Water, Water for Injection (WFI), Clean Steam, Compressed Air
• Experience with process equipment including filling lines, packaging equipment, CIP/SIP systems, and manufacturing equipment.
• Familiarity with CMMS and calibration management systems.
• Experience managing contractors and external calibration service providers.
• Experience supporting regulatory inspections by FDA, AIFA
• Excellent knowledge of written and spoken English

Responsibilities

• Managing the site calibration program for Utilities and Process Equipment.
• Ensuring all calibration activities are performed in compliance with GMP, regulatory requirements, and internal procedures.
• Developing and maintaining the calibration master plan and ensuring timely execution of scheduled activities.
• Managing calibration records, certificates, and documentation to ensure data integrity and inspection readiness.
• Coordinating internal resources and external service providers performing calibration activities.
• Supporting qualification, validation, commissioning, and start-up activities for new equipment and utilities.
• Defining calibration strategies, intervals, tolerances, and acceptance criteria based on risk assessment and regulatory expectations.
• Managing deviations, investigations, change controls, and CAPAs related to calibration systems.
• Ensuring the calibration status of critical instruments used in manufacturing, utilities, laboratories, and packaging areas.
• Monitoring KPIs related to calibration performance and implementing continuous improvement initiatives.
• Supporting internal and external audits as the subject matter expert for calibration processes.
• Leading and developing the calibration team while promoting a culture of safety, quality, and operational excellence.

Skills

English proficiency

Calibration principles

GMP knowledge

Data integrity

Project management

Education

Engineering degree or related technical discipline

Tools

CMMS

Calibration management systems

Job description

Chiesi Group in Nerviano, Milan, is seeking a Calibration Manager to lead the calibration program for utilities and process equipment across the site, ensuring GMP compliance and data integrity while collaborating with engineering, manufacturing, QA, Validation and Maintenance.

You will develop the calibration master plan, manage records and documentation, coordinate internal and external resources, support qualification and commissioning of new equipment, and drive continuous improvement