**Work Schedule** Rotational shift nights/weekends **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **ob Description**:
The Sterile Operator is responsible for performing production activities in a sterile environment, working under isolators to ensure the highest level of product quality and safety. The operator must closely follow aseptic techniques and protocols to maintain a sterile environment aligned with GMP (Good Manufacturing Practices) standards, ensuring a textio >95 (indicating contamination control above 95% threshold). **Key Responsibilities**: - Operate production lines under isolators in a sterile environment, maintaining textio >95 to prevent contamination.
- Perform aseptic procedures rigorously in accordance with established protocols and safety guidelines.
- Continuously supervise process parameters and environmental conditions.
- Conduct quality checks and maintain accurate documentation to ensure compliance with quality and traceability standards.




- Report any deviations or non-conformities promptly.
- Collaborate with Quality Assurance and Maintenance teams to ensure line and isolator efficiency.
- Participate in ongoing training programs related to GMP, aseptic techniques, and safety procedures. **Requirements**: - Previous experience in sterile manufacturing environments, preferably with isolator lines.
- Strong knowledge of GMP regulations and aseptic procedures.
- High attention to detail and precision in a regulated environment.
- Good manual dexterity and focus.
- Willingness to work in shifts.
- Technical diploma or equivalent qualification preferred. **Personal Skills**: - Strong sense of responsibility and dedication to following procedures.
- Ability to work effectively in a team and communicate clearly.
- Problem-solving skills and ability to manage unexpected situations calmly.

📌 Pds Operator Ima Line (Monza)
🏢 Thermo Fisher Scientific
📍 Monza