Calibration Program Lead - GMP Utilities & Equipment

Biopharma Careers; Milano; In loco; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Remote work options

Tax assistance for foreign colleagues

Descrizione del lavoro

Chiesi, based in Nerviano near Milan, is seeking a Calibration Manager to lead the calibration program for utilities and process equipment at the site, ensuring GMP compliance and data integrity across all activities.

You will collaborate with engineering, manufacturing, QA, validation, and maintenance to plan, execute, and continuously improve calibration activities, while managing records, deviations, and supplier relationships.

Competenze

• Degree in Engineering or a related scientific discipline.
• 5+ years in calibration, maintenance, engineering, or similar within pharma/GMP.
• Strong knowledge of calibration for process instrumentation and utilities.
• Experience with GMP, Data Integrity, and pharmaceutical quality systems.
• Familiar with HVAC, Purified Water, Water for Injection (WFI), Clean Steam, Compressed Air.
• Experience with process equipment like filling lines, CIP/SIP systems, and manufacturing equipment.
• Familiar with CMMS and calibration management systems.
• Experience managing contractors and external calibration providers.
• Experience supporting regulatory inspections (FDA, AIFA).
• Excellent written and spoken English.

Mansioni

• 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.

Conoscenze

Engineering degree

Calibration

GMP knowledge

Data integrity

CMMS

External vendors

Regulatory inspections

English fluency

Formazione

Engineering degree

Strumenti

CMMS software

Calibration management systems

Descrizione del lavoro

Chiesi, based in Nerviano near Milan, is seeking a Calibration Manager to lead the calibration program for utilities and process equipment at the site, ensuring GMP compliance and data integrity across all activities.

You will collaborate with engineering, manufacturing, QA, validation, and maintenance to plan, execute, and continuously improve calibration activities, while managing records, deviations, and supplier relationships.