for the site Borgo San Michele LT, Italy Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing
- that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs. Engineering Validation Specialist for the site Borgo San Michele LT, Italy Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing
- that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs. Your

key responsibilities
* Prepare, review, and maintain GMP documentation, including URS, DQ, IQ, OQ, PQ, qualification protocols, and final reports, in accordance with internal procedures and regulatory expectations.
* Ensure the analysis and evaluation of raw technical data and documentation related to equipment and instruments subject to qualification,



in order to acquire the information necessary for defining procedures/protocols
* Coordinate qualification activities for manufacturing equipment, process systems, utilities, and laboratory instruments.
* Support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
* Assess qualification impact of deviations, change controls, CAPAs, and maintenance activities.
* Ensure qualification documentation is generated, reviewed, and archived in accordance with GMP requirements and data integrity principles.
* Collaborate with Engineering, Production, Quality Assurance, Validation, Maintenance, and external suppliers to ensure timely project completion
* Participate in regulatory inspections and customer audits, providing technical support and qualification documentation as required.
* Contribute to the development and continuous improvement of qualification procedures, templates, and validation strategies.
* In collaboration with the Purchasing Department, prepare requests for quotation to suppliers and support the Manager in preparing a technical and economic evaluation of the offers received.

Your profile
* Bachelor’s or Master’s degree in a scientific or engineering discipline (e.g. Chemistry, Biotechnology, Engineering,



Pharmacy).
* Minimum 2–3 years of experience in qualification and/or validation roles within pharmaceutical or biotechnology manufacturing environments, preferably in CDMO organizations.
* Solid knowledge of GMP and relevant international regulatory standards (EMA, FDA).
* Proven experience in the preparation and management of GMP documentation in regulated environments.
* Hands-on experience gained in pharmaceutical production areas utilizing isolator technology, particularly in aseptic and sterile Fill & Finish operations for biologics preferred.
* Knowledge of regulations related to Equipment and Utilities validation, with particular reference to sterile departments (for examples isolator, autoclave, tunnel, VHP).
* Strong attention to detail, accuracy, and ability to manage qualification activities independently.
* Excellent communication skills and ability to work effectively in cross-functional and client-facing environments.
* Good command of the English language (minimum B2 level).
* Proficiency in standard IT tools, including MS Office, document management systems. Your motivation Are you looking for new challenges in a highly competitive environment? And you want to tackle them creativelyand on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions ratherthan problems? What are you waiting for? We would be happy to explain our corporate benefits in a personalconversation #J-18808-Ljbffr

📌 Engineering Validation Specialist (Latina)
🏢 Aenova Group
📍 Latina