for the site Borgo San Michele LT, Italy

Scorra la pagina per visualizzare tutti i requisiti del lavoro e le responsabilità che i candidati selezionati dovranno assumersi.

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 and oversee Sterility Assurance and aseptic processing activities within sterile manufacturing areas, including APS.

- Collaborate with Production, Engineering & Maintenance, MS&T;, Validation and Quality Assurance to identify, assess and mitigate microbiological contamination risks.

- Support the definition and implementation of contamination control requirements for sterile operations, qualification and validation activities.

- Support deviation investigations, root cause analysis and CAPA definition related to sterility assurance and microbiological events.

- Support the implementation, maintenance and periodic review of the Contamination Control Strategy (CCS).

- Provide Sterility Assurance expertise during regulatory inspections, customer audits and corporate assessments.





- Support technology transfer, qualification/validation and continuous improvement projects within sterile manufacturing.

Your profile

-

- University degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry or related fields); Master’s degree preferred.

- At least 3 years of relevant experience in Sterility Assurance, Microbiology, Quality or Manufacturing within a sterile pharmaceutical environment.

- Good knowledge of GMP and EU GMP Annex 1; knowledge of FDA requirements is considered an advantage.

- Experience or solid knowledge of aseptic processing, APS and contamination control principles.

- Knowledge of Contamination Control Strategy principles.

- Good written and spoken English.

- Strong analytical, communication and cross-functional collaboration skills.

- Experience with cleanroom qualification, technology transfer, environmental monitoring and electronic quality systems is considered a plus.

Annual salary range: EUR 3

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? xjncmbx Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems?

Haupt Pharma Latina S.r.l.

-

- Member of the Aenova Group

- Strada Statale 156 dei Monti Lepini

- 04100 Borgo San Michele LT, Italy

#J-18808-Ljbffr

📌 Sterility Assurance Specialist (Latina)
🏢 Aenova Group
📍 Latina