Full time
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
Our strategy includes building teams across our integral network to pioneer and shape the future of PCI.
The Level II Production Operator (Technician II) executes and runs autonomously the batch aseptic manufacturing activities, billable activities, or continuous improvement activities required in the production department, following instructions and standard operating procedures in accordance with the AEMPS, FDA, and other regulatory agencies under supervision. In addition, they must ensure the execution of production plans, following all company safety guidelines. The minimum training time for this position is normally 3 years to develop the full work.
Comply with manufacturing area safety regulations and work practices in accordance with all company health, safety and environmental programs.
Comply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head.




Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies that have been implemented in the plant, as well as with the department's objectives and corporate quality standards.
Participate in the control of the stock of plant consumables, to guarantee their availability.
Collaborate in the investigations of the different quality events (deviations, capas, change controls.).
Inform the direct manager when anomalies are detected in the operation of equipment, as well as human errors, both their own and those of the team's personnel, to ensure the quality of the product manufactured.
Demonstrate a general knowledge of aseptic techniques (maintaining difficult body posture and movement during long periods of time).
activities of the processes of preparation of autoclave cycles and assembly of installations, perform cleaning of production equipment.).
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