Ph3Overview /h3pfor the site Borgo San Michele LT, Italy /ppWould 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. /ph3Fill Finish Manager /h3pfor the site Borgo San Michele LT, Italy /ppWould 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. /ph3Your key responsibilities /h3ulliSupport the implementation and qualification of the new department and sterile production line, with a focus on isolator technology. /liliManage the formulation, filling, and packaging activities for injectable products in a sterile environment. /liliDraft and revise department documentation, including SOPs (Standard Operating Procedures) and operational protocols. /liliManage process deviations and OOS (Out-of-Specification) results, investigating causes and implementing appropriate CAPA (Corrective and Preventive Actions). /liliEnsure the training and ongoing education of staff on operational procedures and new technologies. /liliSupervise and coordinate a team of production operators and technicians. /liliPlan and organize work shifts to ensure optimal coverage. /liliEnsure compliance with cGMP (Good Manufacturing Practices) regulations and internal quality standards. /liliMonitor operational and financial KPIs for the department, identifying and implementing corrective actions to optimize efficiency. /liliCollaborate with the Engineering, Quality, and Maintenance departments to resolve issues and improve processes. /liliManage internal interactions as well as external interactions with Clients, Regulatory Bodies and Suppliers. /li /ulh3Your profile /h3ulliBachelor’s degree in engineering (preferably Chemical, Industrial, or Biomedical), Chemistry, Industrial Chemistry, CTF (Pharmaceutical Chemistry and Technology), or equivalent scientific/technical disciplines. /liliSolid experience (minimum 3-5 years) in supervisory or production management roles within the pharmaceutical or biotechnology sector. /liliProven direct experience in managing sterile production and "fill and finish" processes for injectable biological products. /liliDirect experience with isolator technology is a preferred requirement. /liliIn-depth knowledge of cGMP regulations (including FDA and EMA). /liliExcellent leadership, problem-solving, and communication skills. /liliFluent in English and Italian, written and spoken /li /ulh3Your motivation /h3pAre you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation! /p /p #J-18808-Ljbffr