Manufacturing Specialist

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 through innovative solutions, and we are seeking a dedicated and driven Manufacturing Specialist to join our Manufacturing Department.

The position

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.

Fields of responsibility

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 qualifications

• 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).

Your skills and attributes

• Fluent Spanish and English; excellent technical writing and communication skills.

• 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

• Eligibility to work in Spain.
• Reporting line: Manufacturing Manager.
• Flexible schedule.

The position is located at ALK’s site in Madrid what is in the business area of ​​Ciudad Lineal, very close to the center of Madrid. We have quick access to the Hermanos García Noblejas and Ascao metro stations and we also have a wide bus connection. The manufacturing center is located at Calle Miguel Fleta 19, while the Business Support area is in an annex building located in the Avalon Business Park.

ALK, among other benefits, has a canteen where employees can have breakfast and lunch every day.

If this sounds like a company mission, job and a department you would like to be part of, we hope to receive your CV and application, but please do not send your CV via e-mail due to GDPR rules.