Sterile Supervisor (Milano, IT)

Biopharma Careers; Milano; In loco; EUR 35.000 - 43.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation support

Comprehensive healthcare

Flexible working arrangements

Remote work options

Tax assistance for foreign colleagues

Descrizione del lavoro

CHIESI in Nerviano, Milano, seeks an experienced Sterile Production Supervisor to join a greenfield biologics project. You will help design and start up a next-generation sterile production department, ensuring robust aseptic operations in a state-of-the-art facility.

You will lead process design input, support qualification activities, and supervise day-to-day sterile operations while driving continuous improvement and quality culture.

Competenze

• Degree in Biotechnology, Pharmacy, Biology, Chemical Engineering, or related field.
• 3–5 years of experience in sterile pharmaceutical manufacturing.
• Hands-on experience in biologics manufacturing (aseptic processing, sterile filtration, fill-finish).
• Knowledge of GMP and Annex 1 requirements.
• Strong documentation and deviation management capabilities.

Mansioni

• Contribute to process and facility design discussions, ensuring manufacturability and GMP compliance.
• Support layout review, equipment URS, and operational input during design and procurement phases.
• Participate in FAT/SAT, commissioning, and qualification activities for sterile biologics manufacturing lines.
• Collaborate with MS&T, Engineering, QA, and Validation teams to define robust operational workflows.
• Contribute to the development of SOPs, batch records, training programs, and aseptic practices.
• Supervise day-to-day sterile biologics manufacturing operations (e.g., aseptic processing, filtration, filling, formulation).
• Ensure compliance with GMP, Annex 1, and aseptic processing standards.
• Lead and coach operators in cleanroom behaviors, gowning practices, and aseptic techniques.
• Monitor production performance, deviations, and investigations; drive timely resolution and continuous improvement.
• Support media fills, environmental monitoring oversight, and inspection readiness activities.
• Promote a strong quality and safety culture within the department.

Conoscenze

Sterile operations

Aseptic techniques

Deviation management

Quality culture

Formazione

Biotechnology / Pharmacy / Biology / Chemical Engineering (degree)

Strumenti

Process validation

Equipment qualification

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 8000 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 Parnaiba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.

This is what you will do

We are seeking an experienced and highly motivated Sterile Production Supervisor to join a unique greenfield project focused on biologics manufacturing.

This role offers the opportunity to contribute not only to daily sterile operations, but also to the design, implementation, and start-up of a next-generation sterile production department.

The successful candidate will play a key role in shaping processes, supporting equipment and facility design decisions, and establishing operational standards for a biologics manufacturing environment.

This is a rare opportunity to be part of a site built from the ground up, contributing to technical excellence, compliance, and long-term operational success.

You will be responsible for

• Project & Start-up Phase Contribute to process and facility design discussions, ensuring manufacturability and GMP compliance.
• Support layout review, equipment URS definition, and operational input during design and procurement phases.
• Participate in FAT/SAT, commissioning, and qualification activities for sterile biologics manufacturing lines.
• Collaborate with MS&T, Engineering, QA, and Validation teams to define robust operational workflows.
• Contribute to the development of SOPs, batch records, training programs, and aseptic practices.
• Supervise day-to-day sterile biologics manufacturing operations (e.g., aseptic processing, filtration, filling, formulation).
• Ensure compliance with GMP, Annex 1, and aseptic processing standards.
• Lead and coach operators in cleanroom behaviors, gowning practices, and aseptic techniques.
• Monitor production performance, deviations, and investigations; drive timely resolution and continuous improvement.
• Support media fills, environmental monitoring oversight, and inspection readiness activities.
• Promote a strong quality and safety culture within the department.

You will need to have

• Degree in Biotechnology, Pharmacy, Biology, Chemical Engineering, or related scientific disciplines
• Minimum 3-5 years of experience in sterile pharmaceutical manufacturing.
• Proven hands-on experience in biologics manufacturing (e.g., aseptic processing, sterile filtration, fill-finish, upstream/downstream interfaces).
• Knowledge of GMP and Annex 1 requirements.
• Deep understanding of aseptic techniques and contamination control strategy.
• Familiarity with process validation and equipment qualification.
• Strong documentation and deviation management capabilities.

We would prefer for you to have

• Experience in start-up, scale-up, or facility expansion projects is desirable.
• Exposure to isolators, cleanroom qualification, and media fill execution is a strong advantage.

Location

Nerviano, Milano

Compensation Range

The minimum salary for this role is € 39.000, aligned to our established salary framework. The final offer will reflect the candidate's skills, experience, qualifications and internal equity considerations.

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.