Process & Cleaning Validation Specialist I

In breve

The Process & Cleaning Validation Specialist I will join a pharmaceutical company that designs, manufactures and fills sterile products. The role focuses on evaluating manufacturing process documents and equipment cleaning procedures, creating validation protocols, and executing both process and cleaning validations, including aseptic media fills. Day‑to‑day duties include drafting and updating validation protocols for cleaning, process and media‑fill activities, gathering required parameters from other functions, and coordinating the execution of these protocols. The specialist will perform periodic cleaning verification, manage risk assessments for cross‑contamination, and ensure all activities follow internal SOPs and regulatory expectations. Additional responsibilities cover handling deviations, compiling validation reports, archiving documentation, and providing quality support during new‑product transfers and qualification phases. The position also serves as a subject‑matter expert during design, construction and implementation of new processes or manufacturing areas, and may assist other departments as directed by management. The must‑have qualifications are a bachelor's degree (or equivalent) in a scientific or pharmaceutical discipline such as pharmacy, chemistry, biotechnology or a related field, and at least one year of direct experience in process validation, cleaning validation or aseptic process simulation for sterile products. Candidates must be proficient in Italian at a basic level and possess advanced written and oral English skills. Required technical abilities include familiarity with pharmaceutical techniques, aseptic filling processes, risk management, client‑service or project‑management experience, and competence with Microsoft Office applications such as Word and Excel. Preferred, but not mandatory, attributes include any equivalent combination of education, training and relevant work experience, for example in manufacturing technology, that can substitute for the stated degree or experience requirements. The role operates on a standard Monday‑to‑Friday schedule within an office environment, offering the chance to work closely with cross‑functional teams and to contribute to the company's growth in sterile product manufacturing. What the role asks for: - Bachelor's degree in scientific/pharmaceutical area - Minimum 1 year process or cleaning validation experience - Basic proficiency in Italian - Advanced written and oral English - Knowledge of pharmaceutical techniques - Experience with aseptic filling processes - Risk management competence - Proficiency in Microsoft Word and Excel