Validation Engineer

Chiesi Group; Turbigo; In loco; EUR 40.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Comprehensive healthcare programs

Work-life balance initiatives

Robust relocation support

Flexible working arrangements

Remote work options

Descrizione del lavoro

A renowned biopharmaceutical company in Italy is seeking a Validation Engineer for its new site in Nerviano. The role involves developing Validation Master Plans and overseeing Commissioning and Qualification activities for pharmaceutical manufacturing, specifically respiratory products. Candidates should have a degree in Engineering or related fields and a minimum of 5 years of relevant experience. Offering competitive salary, flexible work arrangements, and comprehensive benefits.

Competenze

• Minimum 5 years of experience in pharmaceutical Commissioning and Qualification.
• Solid knowledge of EU GMP and FDA regulations.
• Demonstrated experience in Systems and Equipment Commissioning.

Mansioni

• Develop Validation Master Plans for Systems and Equipment.
• Support management of Commissioning and Qualification activities.
• Collaborate with cross-functional teams on C&Q activities.

Conoscenze

Commissioning and Qualification

Regulatory Compliance

Communication

Problem-solving

Attention to Detail

Formazione

Degree in Engineering, Pharmacy, Chemistry, or related

Strumenti

EU GMP

FDA CFR 21 Part 11

Annex 15

GAMP 5

Descrizione del lavoro

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/Cleanrooms, 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

Technical Skills

• Commissioning (FAT, SAT, Commissioning) and Qualification (DQ, IQ, OQ, PQ) protocols and lifecycle management.
• Technical knowledge of Systems, Equipment, Facilities, and Utilities of a pharmaceutical manufacturing site and relevant functionalities.
• Compliance with global regulatory standards.
• Data integrity principles and Computerized System Validation (CSV).
• Deviation and change control management.

Soft Skills

• Excellent communication and interpersonal skills.
• Problem-solving mindset and ability to work under pressure.
• High attention to detail.
• Strategic thinking with a proactive, hands-on approach.
• Cross-functional collaboration and stakeholder management.
• Willing to work in a dynamic, challenging and friendly environment

Location

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.