Are you looking for an exciting opportunity to develop your manufacturing skills in a growing, international pharmaceutical company? At ALK, we are on a mission to improve the lives of people living with allergies, and we are seeking a dedicated and driven Manufacturing Specialist to join our Manufacturing Department.
In this role, you’ll be the go‑to manufacturing specialist supporting three core areas: sterile filling, bulk manufacturing, and material preparation. This is a hands‑on, cross‑functional role for a problem‑solver who thrives on the shop floor, champions GMP excellence, drives continuous improvement and enjoys collaborating across teams.
Your key responsibilities:
The Manufacturing Technician supports sterile and non‑sterile production operations, ensuring safe, efficient, and fully compliant processes aligned with GMP and regulatory expectations. Key responsibilities include:
Operational & Technical Support - Provide day‑to‑day technical support across sterile filling, bulk manufacturing, and material preparation.
Operate and oversee critical aseptic manufacturing equipment such as ovens, autoclaves, SAS, RABS, and cleanroom systems.
GMP & Aseptic Compliance - Ensure proper execution of aseptic practices, gowning, line clearance, and environmental monitoring oversight. Support compliance with EU GMP Annex 1 requirements.
Issue Resolution & Investigation - Lead structured problem‑solving for deviations, equipment issues, and process failures. Drive robust CAPA and change control implementation.
Documentation Ownership - Maintain, update, and optimize manufacturing documentation including SOPs, batch records, work instructions, and risk assessments (FMEA).
Cross‑Functional Collaboration - Partner with QA, QC, Engineering, Supply Chain, Validation, and HSE during audits, investigations, media fills, and cleaning validation. Contribute to regulatory inspection readiness.
Equipment & Process Qualification - Support qualification and validation activities
📌 Manufacturing Specialist (Madrid)
🏢 ALK
📍 Madrid