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.