Sterility & Contamination Control Specialist

Aenova Group; Latina; On-site; EUR 30,000 - 40,000; Full time

Job summary

Aenova Group, at the Borgo San Michele LT site, Italy, seeks a Sterility Assurance professional to oversee aseptic processes, QA collaboration, and contamination control in a sterile manufacturing environment. The role requires 3+ years in sterility, microbiology, or related manufacturing fields and strong GMP knowledge.

The candidate will support investigations, CAPA, regulatory inspections, and technology transfer activities, contributing to excellence in sterile production within a leading

Qualifications

• University degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry or related fields).
• Master's degree preferred for advanced roles.

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.

Skills

Sterility Assurance

Microbiology

GMP knowledge

Aseptic processing

Contamination control

English (written/spoken)

Cross-functional collaboration

Regulatory inspections

Technology transfer

Education

University degree in scientific discipline

Master's degree preferred

Job description

Aenova Group, at the Borgo San Michele LT site, Italy, seeks a Sterility Assurance professional to oversee aseptic processes, QA collaboration, and contamination control in a sterile manufacturing environment. The role requires 3+ years in sterility, microbiology, or related manufacturing fields and strong GMP knowledge.

The candidate will support investigations, CAPA, regulatory inspections, and technology transfer activities, contributing to excellence in sterile production within a leading