Manufacturing Specialist (Product Supply)

ALK; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Subsidized meals

Pension plan

Career development opportunities

Descripción de la vacante

ALK is seeking a Manufacturing Specialist to join the Manufacturing Department in Madrid. The role covers sterile filling, bulk manufacturing, and material preparation, working hands-on on the shop floor and driving GMP excellence.

You will lead investigations, CAPA, and change control while collaborating with QA, QC, Engineering, and Supply Chain. Strong English and Spanish, plus Excel and MES/eBR/SAP skills, are required.

Formación

• Degree in Pharmacy, Chemical/Biomedical Engineering, Biotechnology, or related discipline; Master's is a plus.

Responsabilidades

• Provide day-to-day technical support across sterile filling, bulk manufacturing, and material preparation.
• Operate aseptic equipment and ensure compliant GMP processes.
• Lead deviations investigations and implement CAPA and changes.
• Maintain and optimize manufacturing documentation (SOPs, batch records).
• Collaborate with QA, QC, Engineering, Supply Chain, Validation, and HSE.
• Support IQ/OQ/PQ qualifications and validation activities.
• Analyse performance data to identify improvements and drive actions.
• Train teams on GMP, aseptic technique, and MES/eBR/SAP.
• Manage material readiness and FEFO/kanban in operations.
• Support 5S, visual management, and Gemba routines.

Conocimientos

GMP manufacturing

Data integrity

CAPA & deviations

ERP SAP

MES/eBR systems

Excel

Cross-functional collaboration

Lean/Six Sigma

Educación

Degree in Pharmacy

Chemical/Biomedical Engineering

Biotechnology

Master's degree is a plus

Herramientas

MES/eBR

SAP

Excel

Descripción del empleo

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.