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 versátil 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.

#J-18808-Ljbffr

📌 Manufacturing Specialist (Product Supply) (Madrid)
🏢 ALK
📍 Madrid