)
)
Solution Supply Specialist (M/F/D)
Tasks:
Weigh & Dispense (W&D): Perform routine operator activities within W&D, raw material staging, material transfers, visual inspection, and inventory control in strict adherence to GMP and GDocP requirements.
Buffer & Media Preparation: Execute routine formulation, sterile filtration, and supply activities to provide critical buffers and media for Upstream (USP) and Downstream (DSP) processing.
Equipment & Cleanroom Operations: Operate, set up, and prepare process equipment in strict adherence to electronic/paper batch records and SOPs. Maintain the GMP status of formulation areas.
Single-Use & Stainless Steel Systems: Assist with the assembly, preparation, and disassembly of single-use systems (SUS) (e.g., bags, tubing, filters) and traditional stainless steel formulation vessels
Equipment Upkeep & Prep: Support cleaning validation cycles, parts washing, autoclave operations (in compliance with validated cycles), calibration, and routine equipment maintenance.
Process Sampling: Execute critical process sampling (e.g., pH, conductivity, bioburden) in accordance with approved sampling plans and SOPs.
Quality & Document Control: Support the authoring, revision, and maintenance of Standard Operating Procedures (SOPs), sampling plans, and departmental procedures to ensure compliance with GMP and GDocP requirements.
Digitization & MES: Support the onboarding, testing, training, and execution of Manufacturing Execution Systems (MES / Electronic Batch Records) and align them with paper batch records to drive digitization in Solution Supply.
Deviation & Risk Management: Lead, investigate, and escalate deviations occurring within Solution Supply. Act as a Quality Risk Assessment (QRA) and Change Champion to drive compliance, process robustness, and operational optimization.
Qualification:
Education: Technical or scientific vocational training (e.g., Biotech/Chemical Laboratory Technician, Chemical Operator, Druggist/Pharmacist Assistant) or equivalent practical experience.
Experience: Minimum of 3 years of hands-on manufacturing experience within a GMP-regulated biopharmaceutical or pharmaceutical environment (specifically in solution preparation, formulation, or central services).
Core Systems: Prior exposure to both paper-based batch records and electronic systems (e.g., MES, EBR, LIMS, SAP).
GMP & Compliance: Strong, practical understanding of Good Documentation Practices (GDP) and ALCOA+ principles.
Equipment Expertise: Experience operating single-use systems, parts washers, autoclaves, and analytical benchtop instruments (e.g., pH/conductivity meters).
Problem-Solving: Proven ability to troubleshoot equipment/process issues and support deviation investigations to root cause.
Language Proficiency: Professional working proficiency in both German and English (written and spoken) is preferred
Cleanroom Readiness: Comfortable working in classified cleanroom environments (including gowning and physical handling of raw materials).
Requirements:
Start: 01.10.2026
Duration: 12 months
Capacity: 5 days per week
Location: Werthenstein, Switzerland
)