Engineering Equipment & CSV Manager

for the site Borgo San Michele LT, Italy Engineering Equipment & CSV Manager Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs. Your key responsibilities Oversee the qualification activities of plants, equipment, classified environments, and critical systems according to GMP regulations. Coordinate qualification activities with involved departments: Engineering, Production, Quality, Maintenance, and HSE. Quantify the budget for qualification activities. Support internal and external audits, regulatory inspections, and periodic reviews of qualified systems. Ensure traceability, compliance, and data integrity during qualification activities. Monitor qualification status of corporate assets and manage system lifecycle according to policies. Your profile Degree in scientific or engineering disciplines (e.g., Chemistry, Biotechnology, Engineering, Pharmaceutical Chemistry and Technology). Minimum 5 years’ experience in qualification/validation in pharmaceutical companies. Deep knowledge of GMP, GAMP, and international standards (e.g., FDA, EMA). Attention to detail and ability to manage activities independently. Good interpersonal skills and team collaboration abilities. English proficiency (B2 level). Proficiency with IT tools (MS Office, document management systems, ERP). Your motivation Are you seeking new challenges in a competitive environment? Do you want to approach them creatively and responsibly? If you prefer a 'get-it-done' culture and solution-oriented thinking, what are you waiting for? We look forward to discussing our corporate benefits with you in a personal conversation! J-18808-Ljbffr

Location: Borgo San Michele, Lazio, IT

Posted Date: 8/17/2025