Manufacturing Specialist (Product Supply)

ALK-Abelló A/S; Madrid; Presencial; EUR 42.000 - 64.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Subsidized meals

Pension plan

Descripción de la vacante

ALK-Abelló A/S in Madrid seeks a Manufacturing Specialist to support sterile filling, bulk manufacturing and material preparation on the shop floor, driving GMP excellence and continuous improvement.

The role requires 3–5 years in GMP pharma/biotech manufacturing, preferably with sterile/aseptic experience, and fluency in Spanish and English. You will work with QA, QC, Engineering, Supply Chain, Validation, and HSE to ensure compliant operations.

Formación

• 3–5 years’ experience in GMP pharmaceutical/biotech manufacturing, ideally with sterile/aseptic operations.
• Fluent in Spanish and English; excellent technical writing and communication skills.
• Strong knowledge of EU GMP Annex 1 and data integrity, validation, and investigation methodologies.

Responsabilidades

• Provide day‑to‑day technical support across sterile filling, bulk manufacturing, and material preparation.
• Lead structured problem‑solving for deviations, equipment issues, and process failures; drive CAPA and change control.
• Ensure compliance with aseptic practices, gowning, line clearance, and environmental monitoring oversight.
• Maintain, update, and optimize manufacturing documentation (SOPs, batch records, work instructions, risk assessments).
• Collaborate with QA, QC, Engineering, Supply Chain, Validation, and HSE during audits, investigations, media fills and cleaning validation.

Conocimientos

GMP knowledge

Data analysis

Problem-solving

Cross-functional collaboration

Documentation

Training

Lean Six Sigma

Excel

Communication

MES/eBR knowledge

Educación

Degree in Pharmacy, Chemical/Biomedical Engineering, Biotechnology or related (Master’s is a plus)

Herramientas

MES/eBR

SAP

Descripción del empleo

Manufacturing Specialist (Product Supply)

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 flexible 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.