QUALIFICATION & VALIDATION SPECIALIST - #44895

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:

• Managing qualification plans;
• 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;
• Facilitating continuous improvement in quality-related matters.

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:

A contract and salary commensurate with the experience and seniority of the successful candidate.

Job location: