Operate different equipment in one of the functional areas assigned (filling or compounding). Perform filling of syringes following strict aseptic techniques. Perform cleaning and sterilization procedures. Work is performed in aseptic or non-aseptic environments.

Responsibilities

• Perform filling of syringes with biologic product. Clean, prepare and sterilize manufacturing equipment.
• Conduct equipment and facility inspections and raise situations that affect the operating, safety, and environmental conditions.
• Provide technical assistance to manufacturing areas, specifically the troubleshooting support of the equipment and process events.
• Receive, inspect and verify materials availability to be used for the production.
• Document, audit documentation and timely correct manufacturing electronic or paper batch record discrepancies.
• Perform cleaning operations according to the established procedures. Document process and equipment status in the electronic or manual records.
• Monitor critical parameters and raise any deviation that could impact the operations to address accordingly.
• Sample collection and processing as required by the process.
• Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.