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 - thats what we stand for as Aenova one of the worlds leading contract manufacturers and developers for the pharmaceutical industry with 4000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production with a strategic investment plan to become one of Europes 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
- Bachelors 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!
If you have any questions I - Chiara Fanasca / Human Resources - will be happy to help you:
Haupt Pharma Latina S.r.l. Member of the Aenova Group Strada Statale 156 dei Monti Lepini 04100 Borgo San Michele LT Italy
Required Experience:
Manager
Fill & Finish Managerfor the site Borgo San Michele LT ItalyWould 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 - thats what we stand for as Ae...
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 - thats what we stand for as Aenova one of the worlds leading contract manufacturers and developers for the pharmaceutical industry with 4000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production with a strategic investment plan to become one of Europes 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
- Bachelors 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!
If you have any questions I - Chiara Fanasca / Human Resources - will be happy to help you:
Haupt Pharma Latina S.r.l. Member of the Aenova Group Strada Statale 156 dei Monti Lepini 04100 Borgo San Michele LT Italy
Required Experience:
Manager
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