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!

Apply now

If you have any questions, I - Chiara Fanasca / Human Resources - will be happy to help you: Chiara.Fanasca@aenova-group.com

Haupt Pharma Latina S.r.l. • Member of the Aenova Group • Strada Statale 156 dei Monti Lepini • 04100 Borgo San Michele LT, Italy