Experteer Overview
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 / Ventajas
• 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.
• 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