Manufacturing Technician I in León

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Production Operator Level I (Technician I) learns and executes aseptic batch manufacturing activities, billable activities, or continuous improvement initiatives required in the Production department, following instructions and standard operating procedures (SOP) and complying with AEMPS, FDA, and other regulatory agency requirements, under supervision. Likewise, they ensure the correct execution of production plans, respecting the company's safety rules at all times.

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• Main responsibilities

  • Comply with safety rules and work practices in the manufacturing area, in accordance with all corporate Health, Safety, and Environment programs.
  • Work in a team, maintaining an accessible, practical, and motivating attitude, supporting and inspiring colleagues.
  • Participate in quarterly performance conversations ("Quarterly Conversation").
  • Fulfill work programs following the prioritization instructions of their managers to ensure compliance with planning together with the department manager.
  • Collaborate in the identification of continuous improvement opportunities to optimize processes and practices.
  • Comply with the requirements of cGMP, AEMPS, FDA, and other regulatory agency regulations implemented in the plant, as well as departmental objectives and corporate quality standards.
  • Collaborate and participate in the preparation for regulatory agency or customer inspections.
  • Participate in the control of plant consumable stock to guarantee availability.
  • Collaborate in investigations related to quality events (deviations, CAPAs, change controls, etc.).
  • Inform the direct manager when anomalies in equipment operation are detected, as well as personal or team human errors, in order to guarantee the quality of the manufactured product.
  • Inform the direct manager about detected needs regarding safety or human resources.
  • Collaborate with other departments when necessary.
  • Care for and ensure the correct functioning of equipment.
  • Operate production equipment following the guidelines established in the work procedures.
  • Participate in the manufacturing of different products following the Manufacturing Guides and complying with GMP regulations.
  • Handle pallet jacks for the movement of materials and goods.
  • Demonstrate general knowledge of aseptic techniques.
  • Participate satisfactorily in aseptic gowning qualification and in the Media Fill program.
  • Review the corresponding SOPs and production batch records when necessary.
  • Complete and maintain documentation associated with the assigned work, including notebooks, batch records, and other required documentation.
  • Maintain the cleanliness and order of production areas in accordance with established procedures.
  • Perform dispensing and preparation activities of materials necessary for the department's activities.
  • Perform the sanitization of materials before their introduction into the manufacturing areas.
  • Disinfect and clean production rooms.
  • Support formulation process activities.
  • Support filtration process activities.
  • Support activities related to the preparation of autoclave cycles and the assembly of installations.
  • Support Production equipment qualification activities.
  • Perform the cleaning of production equipment.
  • Support the manufacturing of different products following the Manufacturing Guides and complying with GMP regulations.
  • Support the execution activities of SIP (Sterilization In Place) cycles on sterilizable equipment.