Aseptic Fill & Finish Operator | GMP Production

Eurofins Scientific - Nederland; Leiden; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Specialist training

Flexible working hours

Room for ideas

Competitive salary and benefits

Job summary

Eurofins Scientific in Leiden, Netherlands, is seeking a Filling Line Operator for aseptic Fill & Finish in a GMP-regulated production environment. You will operate, monitor and support the aseptic filling line and isolator, contribute to upstream/downstream steps, and assist with APS campaigns and GMP documentation.

Fluency in English and a relevant science degree are required; experience in cleanrooms and GMP environments is preferred, with a hands-on, precise approach and teamwork across QA,

Qualifications

• Must have MLO, HLO or BSc/MSc in Biotechnology, Biochemistry, Life Sciences or a related field.
• Experience in a production, laboratory or cleanroom environment; aseptic processing preferred.
• GMP knowledge, documentation discipline, data integrity and contamination control.
• Experience with GMP documentation, deviations, CAPAs or change controls is a plus.
• Able to work accurately according to written procedures and quality standards.
• Ability to balance hands-on operations with documentation and process improvement tasks.
• Shows ownership, identifies issues and communicates quality/safety concerns.
• Fluent in English, both written and spoken.

Responsibilities

• Prepare, set up, operate, monitor and shut down the aseptic filling line and isolator, including decontamination and cleaning.
• Perform or support upstream and downstream processing activities as required.
• Carry out routine and non-routine interventions and support environmental monitoring and in-process controls.
• Participate in APS campaigns, qualification activities, water runs and GMP manufacturing campaigns.
• Support material transfers, product handling and reconciliation activities.
• Complete GMP documentation, including batch records and logbooks.
• Support non-conformances, investigations, CAPAs, change controls and risk assessments.
• Contribute to qualification, validation, engineering and continuous improvement activities.
• Maintain training and operator qualifications per GMP, EHS and aseptic processing requirements.

Skills

GMP compliance

Documentation

Attention to detail

Team collaboration

English proficiency

Education

MLO/HLO or BSc/MSc in Biotechnology/ Life Sciences

Job description

Eurofins Scientific in Leiden, Netherlands, is seeking a Filling Line Operator for aseptic Fill & Finish in a GMP-regulated production environment. You will operate, monitor and support the aseptic filling line and isolator, contribute to upstream/downstream steps, and assist with APS campaigns and GMP documentation.

Fluency in English and a relevant science degree are required; experience in cleanrooms and GMP environments is preferred, with a hands-on, precise approach and teamwork across QA,