Sterility Assurance Expert

Jefferson Wells; Latina; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical firm in Lazio, Italy, is seeking a Sterility Assurance Expert to ensure compliance with sterility processes and contribute to contamination control strategies. The ideal candidate will have a Master's degree and 5-10 years of relevant experience in sterile environments. Excellent English and strong technical leadership skills are required. This role offers an opportunity to work in a dynamic, multinational environment.

Competenze

• 5-10 years of experience in Sterility Assurance, Microbiology, or Quality Operations.
• In-depth knowledge of GMP, EU GMP Annex 1, and FDA/EMA guidelines.
• Hands-on experience with APS, aseptic processing, and environmental monitoring.

Mansioni

• Ensure implementation and maintenance of the Site Sterility Assurance Program.
• Support aseptic processing activities within sterile manufacturing.
• Collaborate to analyze and mitigate microbiological contamination risks.

Conoscenze

Microbiology

Sterility Assurance

Technical Leadership

Communication

Analytical Skills

Formazione

Master’s degree in a scientific discipline

Strumenti

TrackWise

Veeva

SAP-QM

Descrizione del lavoro

Role Overview

The Sterility Assurance Expert is responsible for ensuring full compliance of aseptic and sterility processes with international regulatory standards (EU GMP, Annex 1, FDA, EMA) and company procedures, while actively contributing to the development and maintenance of a robust Contamination Control Strategy.

This position serves as a technical point of reference for all sterility assurance activities, with a strong focus on biological manufacturing processes, sterile facilities, and critical support systems.

Key Responsibilities

• Ensure the correct implementation, maintenance, and continuous improvement of the Site Sterility Assurance Program.
• Support and oversee aseptic processing activities (dry heat and filtration) and APS within sterile manufacturing departments.
• Collaborate with Production, Engineering&Maintenance, MS&T, Validation and Quality Assurance teams to analyze and mitigate microbiological contamination risks, defining technical standards for sterile operations, design, qualification and validation activities.
• Draft, review, and approve SOPs, protocols, reports, CAPAs, and change controls related to sterility and aseptic processes. Support deviation management, root cause analysis and CAPA definition for microbiological events.
• Define and monitor the Contamination Control Strategy (CCS) and ensure its proper application and periodic review.
• Act as subject matter expert during inspections and audits (regulatory authorities, clients, corporate) for sterility assurance topics.
• Provide training and mentoring to operational and QA / QC personnel on asepsis, sterility, and sterile area behavior.
• Deliver technical guidance and coaching to the Sterility Assurance team.
• Support technology transfer, qualification/validation, and continuous improvement projects in the sterile manufacturing area.
• Ensure alignment with Corporate guidelines, international best practices and relevant regulatory updates.
• Manage technical interactions with clients on all sterility assurance aspects, supporting audits, technical meetings, and scientific or quality discussions.

Minimum Requirements

• Master’s degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, or related fields).
• At least 5-10 years of experience in Sterility Assurance, Microbiology, or Quality Operations within sterile or biological pharmaceutical environments.
• In-depth knowledge of GMP, EU GMP Annex 1 (revised), and FDA/EMA guidelines.
• Hands‑on experience with APS, aseptic processing, and environmental monitoring.
• Familiarity with electronic quality systems (TrackWise, Veeva, SAP‑QM, or equivalent).

Excellent written and spoken English.

Strong communication, analytical, and technical leadership skills in cross‑functional and multinational environments.