Aseptic Manufacturing Floor Lead (GMP, Robotic Isolator)

White Raven - WHITE RAVEN; Luik; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

White Raven manufactures in Liège, Belgium and seeks a Manufacturing Supervisor to lead aseptic floor operations on a Cytiva SA25 robotic isolator platform. You will work hands-on with operators to execute GMP batches, engineering runs and process studies in a Grade C cleanroom.

You will train and qualify operators, ensure GMP/GDP compliance, and collaborate with the Manufacturing Coordinator and Project Manager on campaigns and changeovers.

Qualifications

• Experienced aseptic manufacturing professional with GMP discipline.
• GMP and aseptic expertise required; technical leadership without a formal management layer.

Responsabilités

• Run day-to-day aseptic filling in a fully robotic isolator platform.
• Own floor execution of GMP batches, engineering runs, and process studies.
• Review batch records for GMP and GDP compliance before hand-off to Quality.
• Collaborate with Manufacturing Coordinator on daily production and back-up roles.
• Plan manufacturing contribution to customer projects with project managers.
• Author and review manufacturing docs; maintain BOMs and routings in ERP.
• Ensure GMP adherence and maintain electronic documentation (eBMR, Odoo, QMS).
• Contribute to APS program and monitor process performance (RFT, OEE).
• Train and qualify operators on equipment, procedures, and GMP requirements.
• Lead or support continuous improvement initiatives (5S, Kaizen, DMAIC).
• Investigate deviations and act as CAPA/Change/Task Owner when assigned.
• Lead risk analysis sessions following standard methodologies.
• Collaborate with client auditors and regulators during audits.

Connaissances

GMP discipline

Aseptic expertise

Technical leadership

Outils

Odoo ERP

Scilife QMS

Description du poste

White Raven manufactures in Liège, Belgium and seeks a Manufacturing Supervisor to lead aseptic floor operations on a Cytiva SA25 robotic isolator platform. You will work hands-on with operators to execute GMP batches, engineering runs and process studies in a Grade C cleanroom.

You will train and qualify operators, ensure GMP/GDP compliance, and collaborate with the Manufacturing Coordinator and Project Manager on campaigns and changeovers.