Overview
for the site Borgo San Michele LT, Italy
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.
Fill & Finish Manager
for the site Borgo San Michele LT, Italy
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
* Support the implementation and qualification of the new department and sterile production line, with a focus on isolator technology.
* Manage the formulation, filling, and packaging activities for injectable products in a sterile environment.
* Draft and revise department documentation, including SOPs (Standard Operating Procedures) and operational protocols.
* Manage process deviations and OOS (Out-of-Specification) results, investigating causes and implementing appropriate CAPA (Corrective and Preventive Actions).
* Ensure the training and ongoing education of staff on operational procedures and new technologies.
* Supervise and coordinate a team of production operators and technicians.
* Plan and organize work shifts to ensure optimal coverage.
* Ensure compliance with cGMP (Good Manufacturing Practices) regulations and internal quality standards.
* Monitor operational and financial KPIs for the department, identifying and implementing corrective actions to optimize efficiency.
* Collaborate with the Engineering, Quality, and Maintenance departments to resolve issues and improve processes.
* Manage internal interactions as well as external interactions with Clients, Regulatory Bodies and Suppliers.
Your profile
* Bachelor’s degree in engineering (preferably Chemical, Industrial, or Biomedical), Chemistry, Industrial Chemistry, CTF (Pharmaceutical Chemistry and Technology), or equivalent scientific/technical disciplines.
* Solid experience (minimum 3-5 years) in supervisory or production management roles within the pharmaceutical or biotechnology sector.
* Proven direct experience in managing sterile production and \"fill and finish\" processes for injectable biological products.
* Direct experience with isolator technology is a preferred requirement.
* In-depth knowledge of cGMP regulations (including FDA and EMA).
* Excellent leadership, problem-solving, and communication skills.
* Fluent in English and Italian, written and spoken
Your motivation
Are 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!
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