We are looking for a results-driven, enthusiastic and proactive Upstream Technician to join our Manufacturing Operations Department.
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Main Responsibilities:
As a USP Manufacturing Technician, your responsibilities will include:
- Ensure the timely compliance with the planning of the USP Scale-Up and Manufacturing department previously made by a Team leader.
- Ensure the correct training of the personnel in charge.
- Prepare, control and develop processes for the production of recombinant proteins, monoclonal antibodies or similar biological molecules in microorganisms.
- Participate in internal / external audits as required by the Quality Assurance Department.
- Comply and ensure compliance with GMP standards within the work team.
- Record and manage any quality indicators associated with a scale-up and manufacturing process. Participate in the investigation of the same together with the Team Leader USP (FAB).
- Investigate and propose new methods or process innovations to optimize and improve the work in the area.
- Ensure proper compliance with regulations and correct completion of current documentation.
- Participate in the correct transfer of technologies and resources between companies related to 3P Biopharmaceuticals in collaboration with other departments and their manager.
- Perform the entry documentation of new equipment from the USP Scale-up and Manufacturing area under the supervision of the Team Leader USP (FAB).
- Supervise the correct completion of the new equipment entry documentation.
- Supervise the correct training of the personnel in charge, if any.
- Carry out the distribution and supervision of daily activities.
- Write and keep updated the documentation associated with the production processes carried out in the USP area.
- Control / monitoring of orders placed in the USP production area using ERP software.