PDS Sterile Operator

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profile Job Location:

Monza - Italy

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

Work Schedule

Rotational shift nights/weekends

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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.

Work ScheduleRotational shift nights/weekendsEnvironmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Descriptionob Description:The Sterile Operator is responsible for performing production activities in a sterile environment working under isolators to ensure t...
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