Cross-Functional Aseptic GMP Manufacturing Specialist

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

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.