Process & Cleaning Specialist

Site: Borgo San Michele LT, Italy

Aenova is one of the world's leading contract manufacturers and developers for the pharmaceutical industry, operating 15 sites worldwide with 4,000 employees. Latina is a leading centre of excellence in sterile liquid production and is investing strategically to become a premier European hub.

Your key responsibilities

• Manage and optimize the cleaning processes of production equipment, ensuring compliance with GMP regulations and company procedures.
• Collaborate with manufacturing, quality and engineering teams to develop, validate and monitor cleaning processes (CIP/SIP and manual).
• Draw up and update the technical documentation (SOP, validation protocols, reports) relating to cleaning activities.
• Support investigation activities in case of deviations or non‑conformities related to cleaning processes.
• Participate in the definition and implementation of cleaning validation and cleaning verification strategies.
• Contribute to the continuous improvement of processes through trend analysis and identification of corrective/preventive actions.
• Provide support during internal and external audits (regulatory and clients’) regarding cleaning aspects and related processes.

Your profile

• Degree in Chemistry, Industrial Chemistry, Chemical Engineering, or related scientific disciplines.
• Previous experience (at least 2–3 years) in a similar role in the pharmaceutical or biotechnology sector.
• In-depth knowledge of GMP regulations and EMA/FDA guidelines on cleaning validation.
• Familiarity with the analytical techniques used to verify cleanliness (e.g. TOC, HPLC, visual residues).
• Document management and technical drafting skills in the regulatory field.
• Excellent analytical skills, problem solving and orientation towards continuous improvement.
• Good knowledge of English, written and spoken.
• Aptitude for teamwork and cross‑functional collaboration.