Qualification Specialist

Overview

BSP Pharmaceuticals S.p. A specializes in the development and manufacturing of high‑potency anticancer drugs. Since 2006, BSP has led the fight against cancer, investing in advanced technologies and a high‑containment production plant. As a leading CDMO, BSP delivers contract development and manufacturing services for anticancer therapeutics.

Responsibilities

Qualification Specialist – ensure the analysis, definition and execution of qualification activities for equipment and utilities.

• Technical Documentation Analysis – evaluate technical documentation to acquire information for qualification protocols.
• Qualification Document Definition – draft qualification documents (Risk Assessment, DQ‑IQ‑OQ‑PQ Protocols, Validation Master Plan, Validation Plan, Project Qualification Plan).
• Qualification Execution – perform qualification of equipment and utilities within required time frames, formulate bid requests with the Purchasing function, and support technical and economic bid analyses.
• Qualification Report Preparation – prepare Qualification Reports (DQ‑IQ‑OQ‑PQ Reports) based on data from validation activities.

Qualifications

• Master's Degree in Chemical Engineering, Chemistry or related field.
• Knowledge of regulations for Equipment and Utilities validation, especially for sterile departments.
• At least 2 years of experience in a similar role within complex organizations.
• English language proficiency.
• Can‑do attitude.

Benefits

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, empowering our people to unleash their full potential. We respect diversity, provide equal opportunity for all, and celebrate collaboration.