Job Title: QUALIFICATION & VALIDATION SPECIALIST

Department: QA

Philogen S.p.A. is a biotechnology company whose mission is to develop biologic products for the imaging and treatment of life‑threatening diseases, with a special focus on angiogenesis-related disorders.

Philogen S.p.A. would like to hire a Qualification & Validation Specialist to join the Quality Unit.

In particular, the successful candidate will be responsible for:
- Preparing and verifying qualification and validation documents;
- Drafting thermal validation study protocols and reports;
- Drafting, verifying and executing qualification protocols and tests, including FAT, SAT, IOQ and PQ;
- Performing validation test runs and related activities;
- Drafting and monitoring VMP activities;
- Supporting qualification activities for equipment and utilities, e.g. HVAC systems, water systems and process gases;
- Supporting the Maintenance Department with calibration and maintenance plans and instructions;

The ideal candidate should have:
- A degree in Engineering, Chemistry, Biotechnology,



Pharmaceutical Chemistry and Technology, or a related field;
- A minimum of 3–4 years of experience in the pharmaceutical industry;
- Knowledge of GMP;
- Knowledge of the main methodologies for the risk-based approach, such as FMEA, HACCP, etc.;
- Knowledge of the main validation/calibration instruments: thermal validation loggers, data acquisition systems, calibration instruments, etc.;
- Knowledge of validation procedures and processes: VMP, FAT/SAT, IQ, OQ and PQ.

We offer:
An annual salary package ranging from €35,000 to €45,000, depending on experience and profile.

Job location:
We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientat

📌 QUALIFICATION & VALIDATION SPECIALIST (Siena)
🏢 Philogen
📍 Siena