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Process Engineer II m/w/d (DE)
[17833]
Manufacturing, Weight and Dispensing
We are looking for a Specialist P2 to support GMP-compliant solution supply across Weigh & Dispense, upstream solution supply, and downstream solution supply. The role combines hands-on cleanroom manufacturing with technical-office responsibilities in quality, documentation, deviation management, and MES/electronic batch records. Zu besetzendes Projekt: Process Engineer II m/w/d Art der Beschäftigung: Payroll Branche: Biotech Fähigkeiten: Manufacturing,Weight and Dispensing Projektstart: 01.10.2026 Projektdauer: 12 months Einsatzort: Luzern, Schweiz Key responsibilities Perform Weigh & Dispense, raw-material staging, transfers, and inventory control. Prepare buffers and media, including formulation, sterile filtration, and process sampling. Operate and set up single-use systems, stainless-steel vessels, autoclaves, parts washers, and related equipment. Execute manufacturing activities in accordance with GMP, SOPs, and paper or electronic batch records. Author and revise SOPs, sampling plans, and departmental procedures in line with GDP and ALCOA+ principles. Support MES implementation, testing, training, and electronic batch-record execution. Lead or support deviation investigations, risk assessments, CAPAs, and change controls. Collaborate with QA, QC, Engineering, Automation, and manufacturing teams. Promote a strong EHS culture and support safety risk assessments on the shop floor. Requirements Technical or scientific vocational training or a degree in biotechnology, chemistry, pharmacy, or a related field. At least three years of hands-on GMP manufacturing experience in biopharmaceutical or pharmaceutical operations. Practical experience in solution preparation, formulation, Weigh & Dispense, or central services. Experience with batch records and systems such as MES/EBR, LIMS, SAP, or equivalent. Working knowledge of GMP, GDP, ALCOA+, deviation management, and root-cause analysis. Comfortable working in classified cleanrooms and handling raw materials and process equipment. Professional proficiency in German and English. What you bring You are precise, hands-on, safety-conscious, and comfortable switching between technical documentation and floor operations. You communicate clearly, solve problems pragmatically, and enjoy working in collaborative, cross-functional teams.