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.
#J-18808-Ljbffr
Instruments Calibration Manager (Milano, IT) datore di lavoro: Biopharma Careers
Novartis è un datore di lavoro eccezionale, offrendo un ambiente di lavoro inclusivo e diversificato che valorizza ogni dipendente. Con opportunità di crescita professionale, benefit competitivi e un impegno per l'equità retributiva, i nostri operatori di attrezzature possono prosperare sia personalmente che professionalmente. Inoltre, la flessibilità lavorativa e le politiche di congedo parentale retribuito dimostrano il nostro supporto per il benessere dei dipendenti, rendendo Novartis un luogo ideale per costruire una carriera significativa nel settore farmaceutico.