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).

Practical details:
- 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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Compartir en:

Comunidad Autónoma:

- Comunidad de Madrid

Tipo de trabajo:

Contrato Indefinido

Horas de trabajo:

Jornada completa

Días de trabajo:

Día

Plazo de solicitud:

30/09/2026

Provincia:

Madrid, Spain

Página web:

Dirección de la oficina:

Calle Miguel Fleta 19, 28037 Madrid

Ubicación de la oficina:

ALK-Abelló A/S

ALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy.
ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.
We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.

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