Instruments Calibration Manager
Milano, IT
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.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
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.
You will be responsible for
- 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.
You will need to have
- 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, qualifications and internal equity considerations.
This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.
In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.
What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
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.
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