Aseptic Fill & Finish Operator — GMP, 31 Vacation Days, Flexible Start

Eurofins Group; Leiden; Remote; EUR 32,000 - 48,000; Full time

Benefits offered by this job

Specialist training

31 vacation days per year (full-time)

Mental health platform access

Flexible start time

Bicycle purchase

Job summary

Eurofins Scientific in Leiden is seeking a Filling Line Operator to perform operations within a GMP-regulated production environment, focusing on aseptic Fill & Finish. You will prepare, operate, and monitor the aseptic line and isolator, while supporting upstream/downstream steps and simulations.

You will contribute to GMP documentation, training, and continuous improvement, collaborating with QA, QC and engineering, under strict biosafety standards.

Qualifications

• Fluent in English written and spoken.

Responsibilities

• Preparing, setting up, operating, monitoring and shutting down the aseptic filling line and isolator, including decontamination, glove testing, cleaning and line clearance.
• Performing or supporting upstream and downstream processing activities where required.
• Performing routine and non-routine interventions and supporting environmental monitoring and in-process controls.
• Participating in APS campaigns, qualification activities, water runs, engineering runs and GMP manufacturing campaigns.
• Supporting material transfers, product handling and reconciliation activities.
• Completing and reviewing GMP documentation, including batch records, logbooks, forms and electronic records.
• Supporting non-conformances, investigations, root cause analyses, CAPAs, change controls and risk assessments.
• Contributing to qualification, validation, engineering and continuous improvement activities, including updates to work instructions and procedures.
• Maintaining required training and operator qualifications and working according to GMP, EHS, biosafety and aseptic processing requirements.

Skills

Fluent in English

Education

MLO, HLO or BSc/MSc in Biotechnology, Biochemistry, Life Sciences or related field

Job description

Eurofins Scientific in Leiden is seeking a Filling Line Operator to perform operations within a GMP-regulated production environment, focusing on aseptic Fill & Finish. You will prepare, operate, and monitor the aseptic line and isolator, while supporting upstream/downstream steps and simulations.

You will contribute to GMP documentation, training, and continuous improvement, collaborating with QA, QC and engineering, under strict biosafety standards.