Instruments Calibration Manager (Milano, IT)

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

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

Global Technical Operations & Supply

Global Technical Operations & Supply (Global TechOp&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end-to-end supply chain. Global TechOp&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end-to-end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.

This is what you will do

As a Calibration Manager, you will lead the calibration program for both Utilities and Process Equipment across the manufacturing site, ensuring compliance with GMP requirements and company quality standards. Working closely with engineering, manufacturing, QA, Validation, and Maintenance teams, you will ensure that calibration activities are planned, executed, documented, and continuously improved.

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.

Requirements

• Degree in Engineering or a related scientific discipline or technical diploma.
• Minimum 5 years of experience in calibration, maintenance, engineering, or technical services within the pharmaceutical or other 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.

Location

Nerviano, Milan

Compensation Range

The minimum salary for this role is€ 52.000,aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience,qualificationsand internal equity considerations.

This role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance.

Benefits

• pension, private medical insurance, wellbeing programme, flexible benefits programme.
• comprehensive healthcare programs.
• work-life balance initiatives.
• relocation support.
• basic salary, performance bonuses, and benefits benchmarked against the external market.
• flexible working arrangements, remote work options, and tax assistance services for foreign colleagues.

What we offer

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.