Solution Supply Specialist

K-Recruiting GmbH; Lavamünd; Vor Ort; EUR 75.000 - 106.000; Vollzeit

Zusammenfassung

K-Recruiting GmbH is seeking a Solution Supply Specialist (M/F/D) to support GMP-compliant operations in Werthenstein, Switzerland.

The role covers Weight & Dispense, buffer/media preparation, equipment operation, and MES/EBR digitization, with a 12-month contract and 5-day weeks, starting 01.10.2026.

Qualifikationen

• 3+ years of hands-on manufacturing experience in GMP biopharma or pharma environments.
• Experience with paper-based and electronic batch records.
• German and English working proficiency preferred.

Aufgaben

• Weigh and dispense per GMP and GDocP with inventory control.
• Prepare buffers and media for USP and DSP processing.
• Operate and set up process equipment in cleanrooms.
• Assemble and prep single-use systems and stainless vessels.
• Support cleaning validation, autoclaves, calibration, and maintenance.
• Perform sampling and document results per SOPs.

Kenntnisse

GMP

GDP/ALCOA+

Problem solving

Ausbildung

Technical or scientific vocational training

Equivalent practical experience

Tools

MES

EBR

LIMS

SAP

Jobbeschreibung

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 elevate 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