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:
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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.
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GMP & Aseptic Compliance - Ensure proper execution of aseptic practices, gowning, line clearance, and environmental monitoring oversight. Support compliance with EU GMP Annex 1 requirements.
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Issue Resolution & Investigation - Lead structured problem‑solving for deviations, equipment issues, and process failures. Drive robust CAPA and change control implementation.
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Documentation Ownership - Maintain, update, and optimize manufacturing documentation including SOPs, batch records, work instructions, and risk assessments (FMEA).
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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.
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Equipment & Process Qualification - Support qualification and validation activities (IQ/OQ/PQ) for equipment and manufacturing processes.
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Data Analysis & Continuous Improvement - Analyse performance data (downtime, rejects, EM trends, yield) to identify improvement opportunities. Implement practical improvements with operators and supervisors.
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Training & Capability Building - Train teams in GMP, aseptic technique, standard work, and digital systems such as MES/eBR and SAP. Promote safety‑ and quality‑focused behaviours.
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Material Management - Ensure material readiness through correct handling, segregation, sterilisation, FEFO/kanban application, and availability for sterile and non‑sterile operations.
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Operational Excellence - Support 5S, visual management, and Gemba routines.
Your profile:
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Degree in Pharmacy, Chemical/Biomedical Engineering, Biotechnology, or related discipline (Master’s is a plus).
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3–5 years’ experience in GMP pharmaceutical/biotech manufacturing, ideally with sterile/aseptic operations.
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Strong knowledge of EU GMP (including Annex 1) and manufacturing best practices, data integrity, validation, and investigation methodologies.
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Strong IT skills, especially in Microsoft Excel.
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Experience with manufacturing systems (MES/eBR), and ERP (SAP), plus quality systems (deviation/CAPA/change control).
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Fluent Spanish and English; excellent technical writing and communication skills.
Your skills and attributes:
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Hands‑on, calm under pressure, and comfortable across different manufacturing areas.
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Meticulous attention to detail with a pragmatic, risk‑based approach to compliance and operations.
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Structured problem‑solver with strong analytical skills; confident with data analysis and trending.
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Collaborative and able to influence without authority; strong stakeholder management.
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Proactive continuous improver; Lean/Six Sigma exposure (Green Belt desirable).
Practical details:
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Location: C/ Miguel Fleta, 19 (Madrid, Spain).
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Reporting line: Manufacturing Manager.
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Work pattern: regular day shift with a flexible schedule.
We provide:
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Competitive salary package
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Career development opportunities and continuous training
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Stable employment and a positive work environment
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A comprehensive benefits package including health insurance, subsidized meals, and a pension plan.
