pfor the site Borgo San Michele LT, Italy /p pWould 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.
/p h3Your Key Responsibilities /h3 ul liSupport and oversee Sterility Assurance and aseptic processing activities within sterile manufacturing areas, including APS.
/li liCollaborate with Production, Engineering Maintenance, MST, Validation and Quality Assurance to identify, assess and mitigate microbiological contamination risks.
/li liSupport the definition and implementation of contamination control requirements for sterile operations, qualification and validation activities.
/li liSupport deviation investigations, root cause analysis and CAPA definition related to sterility assurance and microbiological events.
/li liSupport the implementation, maintenance and periodic review of the Contamination Control Strategy (CCS).
/li liProvide Sterility Assurance expertise during regulatory inspections, customer audits and corporate assessments.
/li liSupport technology transfer,



qualification/validation and continuous improvement projects within sterile manufacturing.
/li /ul h3Your profile /h3 ul liUniversity degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry or related fields); Master's degree preferred.
/li liAt least 3 years of relevant experience in Sterility Assurance, Microbiology, Quality or Manufacturing within a sterile pharmaceutical environment.
/li liGood knowledge of GMP and EU GMP Annex 1; knowledge of FDA requirements is considered an advantage.
/li liExperience or solid knowledge of aseptic processing, APS and contamination control principles.
/li liKnowledge of Contamination Control Strategy principles.
/li liGood written and spoken English.
/li liStrong analytical, communication and cross-functional collaboration skills.
/li liExperience with cleanroom qualification, technology transfer, environmental monitoring and electronic quality systems is considered a plus.
/li /ul pAnnual salary range: EUR *************** /p h3Your motivation /h3 pAre 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?
/p pHaupt Pharma Latina S.r.l. /p ul liMember of the Aenova Group /li liStrada Statale 156 dei Monti Lepini /li li***** Borgo San Michele LT, Italy /li /ul #J-*****-Ljbffr

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