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Manufacturing Technician I (Aseptic Production)

PCI Pharma Services · León

Mid 🇬🇧 English

Job description

About the role

The Level VI Production Operator (Technician IV) is responsible for autonomous execution, guidance and leadership of complex aseptic manufacturing activities. Working in a regulated biopharma environment, the role ensures batch production, billable activities and continuous‑improvement projects are carried out safely and in compliance with cGMP, AEMPS and FDA standards.

Key responsibilities

  • Execute aseptic manufacturing batches following SOPs and regulatory requirements.
  • Maintain production schedules, safety guidelines and quality standards.
  • Participate in continuous‑improvement initiatives and identify process optimisation opportunities.
  • Prepare for and support regulatory inspections.
  • Control consumable stock, operate pallet trucks and ensure equipment functionality.
  • Document work in batch records, notebooks and other required forms.
  • Investigate quality events such as deviations, CAPA and change controls.

Required profile

  • Minimum of 5 years experience in aseptic or regulated manufacturing.
  • Detail‑oriented with the ability to work autonomously and follow strict procedures.
  • Team‑oriented, approachable and capable of motivating co‑workers.
  • Ability to prioritize tasks according to senior management instructions.

Required skills

  • Aseptic manufacturing processes
  • cGMP compliance
  • FDA regulatory knowledge
  • AEMPS regulatory knowledge
  • Production equipment operation
  • Pallet truck operation
  • Batch record documentation
  • Quality investigation (deviation, CAPA, change control)

What we offer

  • Opportunity to work on life‑changing therapies with global impact.
  • Collaborative environment focused on continuous improvement.
  • Access to training and development within a leading biopharma network.

Questions fréquentes

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Published 4 months ago

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PCI Pharma Services

León