Validation Engineer

We are looking for a Validation Engineer to join our team in Nerviano, Italy. As a Validation Engineer, you will be responsible for the execution and coordination of Commissioning and Qualification activities at our pharmaceutical manufacturing site. You will develop Validation Master Plans, support the Validation Manager, and execute Qualification Protocols for Systems, Equipment, Facilities, and Utilities. You will need to have a degree in Engineering, Pharmacy, Chemistry, or a related scientific discipline and a minimum of 5 years of experience in pharmaceutical Commissioning and Qualification. Solid knowledge of EU GMP, FDA CFR 21 Part 11, Annex 15, GAMP 5, and validation best practices is required.

Requirements

• Degree in Engineering, Pharmacy, Chemistry, or related scientific discipline
• Minimum 5 years of experience in pharmaceutical Commissioning and Qualification
• 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)
• Technical Skills: Commissioning (FAT, SAT, Commissioning) and Qualification (DQ, IQ, OQ, PQ) protocols and lifecycle 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

Benefits

• Comprehensive healthcare programs
• Work-life balance initiatives
• Robust relocation support
• Flexible working arrangements
• Remote work options
• Tax assistance services for foreign colleagues