Experteer Overview

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You join ALK’s Manufacturing Department as a hands-on specialist supporting sterile filling, bulk manufacturing, and material preparation. You will drive GMP compliance, continuous improvement, and cross-functional collaboration on the shop floor. Your focus is on reliable, compliant operations and efficient problem solving to keep production advancing.

This role offers hands-on exposure to aseptic processes, equipment qualification, and data-driven improvements. You will contribute to a mission‑driven environment that improves lives of people living with allergies.

Compensaciones / Incentivos

- Provide day-to-day technical support across sterile filling, bulk manufacturing, and material preparation.
- Operate and oversee aseptic equipment like ovens, autoclaves, SAS, RABS, and cleanroom systems.
- Ensure aseptic practices, gowning, line clearance, and environmental monitoring align with EU GMP Annex 1.
- Lead structured problem-solving for deviations, equipment issues, and process failures; implement CAPA and change control.




- Maintain and optimize manufacturing documentation (SOPs, batch records, work instructions, risk assessments).
- Collaborate with QA, QC, Engineering, Supply Chain, Validation, and HSE during audits and investigations.
- Support IQ/OQ/PQ qualification and validation activities for equipment and processes.
- Analyze performance data to identify improvement opportunities and implement practical changes with operators.

Responsabilidades

- 3–5 years' experience in GMP pharmaceutical/biotech manufacturing, ideally with sterile/aseptic operations.
- Strong knowledge of EU GMP (including Annex 1) and data integrity, validation, and investigation methodologies.
- Strong IT skills, especially Microsoft Excel.
- Experience with MES/eBR and SAP; familiarity with deviation, CAPA, and change control systems. xugodme
- Fluent in Spanish and English; excellent technical writing and communication skills.

Requisitos principales

- competitive salary
- career development opportunities
- continuous training
- health insurance
- subsidized meals
- pension plan

📌 Manufacturing Specialist (Product Supply) (Madrid)
🏢 Alk Abello
📍 Madrid