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Manufacturing Technician II

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PCI Pharma Services

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Location:
Spain , Leon

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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. A high level of detail is required due to the complexity of the activities to be performed. The minimum training time for this position is normally 3 years to develop the full work.

Job Responsibility:

  • Executes and runs autonomously the batch aseptic manufacturing activities, billable activities, or continuous improvement activities required in the production department
  • Ensure the execution of production plans, following all company safety guidelines

Requirements:

  • Comply with manufacturing area safety regulations and work practices
  • Work as a team, being approachable, practical, motivating
  • Comply with the schedule by following prioritization instructions
  • Collaborate in the identification of opportunities for continuous improvement
  • Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies
  • Collaborate and participate in preparing for inspections by regulatory agencies or clients
  • Participate in the control of the stock of plant consumables
  • Collaborate in the investigations of quality events (deviations, capas, change controls)
  • Inform the direct manager when anomalies are detected
  • Inform the direct manager if safety equipment or human resources needs are identified
  • Collaborate in teamwork with other departments
  • Take care of and ensure the proper functioning of equipment
  • Operate production equipment following guidelines
  • Participate in the manufacture of products following manufacturing guides
  • Handle pallet trucks for the movement of goods
  • Review relevant SOPs and production lot records
  • Complete and maintain documentation
  • Comply with and maintain cleanliness and order of production areas
  • Supports the manufacture of products
  • Supports the activities of the qualification of production equipment
  • Demonstrate a general knowledge of aseptic techniques
  • Successful participation in the gowning qualification as well as the media fill plan
  • Leads the activities of dispensing and preparing materials
  • Perform the sanitization of materials
  • Disinfect classified and non-classified clean production rooms
  • Leads the activities of set up grade D/C
  • Supports the activities of set up grade A/B
  • Leads the activities of formulation processes grade C
  • Supports the activities of formulation processes grade A/B
  • Leads the activities of filtration processes grade C
  • Supports the activities of filtration processes grade AB
  • Supports filling activities
  • Supports the activities of SIP execution of sterilizable equipment
  • Trains Technicians level I

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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