This job is no longer available
This job expired on 18/07/2026. It no longer accepts applications.
Manufacturing Technician I (Aseptic Production)
PCI Pharma Services · León
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.
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PCI Pharma Services
León
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