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 (IQ/OQ/PQ) for equipment and manufacturing processes.
Data Analysis & Continuous Improvement - Analyse performance data (downtime, rejects, EM trends, yield) to identify improvement opportunities. Implement practical improvements with operators and supervisors.
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.
Material Management - Ensure material readiness through correct handling, segregation, sterilisation, FEFO/kanban application, and availability for sterile and non-sterile operations.
Operational Excellence - Support 5S, visual management, and Gemba routines.
Your profile:
Degree in Pharmacy, Chemical/Biomedical Engineering, Biotechnology,



or related discipline (Master's is a plus).
3-5 years' experience in GMP pharmaceutical/biotech manufacturing ideally with sterile/aseptic operations.
Strong knowledge of EU GMP (including Annex 1 ) and manufacturing best practices, data integrity, validation, and investigation methodologies.
Strong IT skills, especially in Microsoft Excel .
Experience with manufacturing systems (MES/eBR), and ERP (SAP), plus quality systems (deviation/CAPA/change control).
Fluent Spanish and English;
excellent technical writing and communication skills.
Your skills and attributes:
Hands-on, calm under pressure, and comfortable across different manufacturing areas.
Meticulous attention to detail with a pragmatic, risk-based approach to compliance and operations.
Structured problem-solver with strong analytical skills;
confident with data analysis and trending.
Collaborative and able to influence without authority;
strong stakeholder management.
Proactive continuous improver;
Lean/Six Sigma exposure(Green Belt desirable).
Location: C/ Miguel Fleta, 19 (Madrid, Spain).
Reporting line: Manufacturing Manager.
Work pattern: regular day shift with a adaptable schedule.
We provide:
Competitive salary package
Career development opportunities and continuous training
Stable employment and a positive work environment
A comprehensive benefits package including health insurance, subsidized meals, and a pension plan.
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📌 Manufacturing Specialist (Product Supply) (Madrid)
🏢 ALK
📍 Madrid