Validation Engineer

Location: Turbigo

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.
Chiesi Global Manufacturing Division    Chiesi Group has three production plants:
Parma   (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.
In 2024, a new  Biotech Centre of Excellence   has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.
Blois-La Chaussée Saint Victor plant   (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.
Santana de Parnaiba   (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).
In 2025, a new investment in  Nerviano   (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.
Who we are looking for    This is what you will do    For our new Site in Nerviano (Milan) we are looking for a new Validation Engineer.
The  Validation Engineer   is responsible for the execution and coordination of the Commissioning and Qualification activities relevant to Systems, Equipment, Facilities, and Utilities at the pharmaceutical manufacturing site, specialized in respiratory spray and bio-pharmaceuticals products.
You will be responsible for      Develop  Validation Master Plans (VMP)   for Systems, Equipment, Facilities, and Utilities according to Chiesi standards.
Support the Validation Manager in the  management of the Commissioning and Qualification activities (FAT, SAT, DQ, IQ, OQ, PQ)  .
Prepare, or oversight external partners in the preparation, of Qualification Protocols for Systems, Equipment, Facilities, and Utilities.
Execute, or oversight external partners in the execution, of Qualification Protocols for Systems, Equipment, Facilities, and Utilities.
Oversight Equipment Vendors and Contractors   in the execution of FAT, SAT and Commissioning activities, ensuring compliance to Chiesi standards.
Review and approve  FAT, SAT, Commissioning and Technical Documentation   issued by Equipment Vendors and Contractors.
Assure  Data integrity   application.
Support the Validation Manager in the management and implementation of the  Change Controls   on qualified Systems and Equipment.
Collaborate with cross-functional teams, including Engineering, Maintenance, Production, Quality Control and QA for C&Q activities.
You will need to have      Degree in  Engineering, Pharmacy, Chemistry, or related scientific   discipline.
Minimum  5 years of experience   in pharmaceutical Commissioning and Qualification, preferably on  large scale Projects  .
Solid knowledge of  EU GMP, FDA CFR 21 Part 11, Annex 15, GAMP 5  , and validation best practices.

Experience with  aseptic/sterile production  , preferably in  respiratory devices and biopharmaceuticals  .
Demonstrated experience in  Systems and Equipment Commissioning and Qualification  , including HVAC/Clean rooms, Clean media and Process Equipment.
Experience in  FAT, SAT and Commissioning   activities.
Strong understanding of  risk management   methodologies (e.g., FMEA, QRM).
Fluent in English   (written and spoken). Any other language will be considered as a plus.
We would prefer for you to have   …