pulli12 months contract with extension optionbr/ /li /ululliInternational biotech company /lili12 months contract with extension optionbr/ /li /ulh3About Our Client /h3pFor our client, an international biotech company in Lucerne area, we are looking for a Solution Supply Specialist (a). This role offers a perfect balance between technical office work (deviation management, SOP/MES authoring, and digitization) and active on-the-floor operations in Weigh Dispense (WD) and Buffer/Media Preparation. Start in bOctober /b, for the next 12 months with extension option. /ph3Job Description /h3pKey responsibilities include: /ph3The Successful Applicant /h3h3What's on Offer /h3ulliTechnical Office Work, Compliance Deviation Management /liliQuality 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. /liliDigitization 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. /liliDeviation 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. /liliCross-Functional Collaboration: Lead and participate daily in cross-functional teams to collaboratively address and cover compliance, quality, and technical deliverables under direction. /liliOn-the-Floor Operations (WD Solution Supply) /liliWeigh Dispense (WD): Perform routine operator activities within WD, raw material staging, material transfers, visual inspection, and inventory control in strict adherence to GMP and GDocP requirements. /liliBuffer Media Preparation: Execute routine formulation, sterile filtration, and supply activities to provide critical buffers and media for Upstream (USP) and Downstream (DSP) processing. /liliEquipment 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. /liliSingle-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. /liliEquipment Upkeep Prep: Support cleaning validation cycles, parts washing, autoclave operations (in compliance with validated cycles), calibration, and routine equipment maintenance. /liliProcess Sampling: Execute critical process sampling (e.g., pH, conductivity, bioburden) in accordance with approved sampling plans and SOPs. /liliEHS Risk Assessments: Lead, facilitate, and participate in EHS risk assessments and site safety initiative implementations on-floor. /liliTechnical or scientific vocational training (e.g., Biotech/Chemical Laboratory Technician, Chemical Operator, Druggist/Pharmacist Assistant) or equivalent practical experience. /lili3+ years of hands-on manufacturing experience within a GMP-regulated biopharmaceutical or pharmaceutical environment (specifically in solution preparation, formulation, or central services). /liliPrior exposure to both paper-based batch records and electronic systems (e.g., MES, EBR, LIMS, SAP). /liliGMP Compliance: Strong, practical understanding of Good Documentation Practices (GDP) and ALCOA+ principles. /liliExperience operating single-use systems, parts washers, autoclaves, and analytical benchtop instruments (e.g., pH/conductivity meters). /liliProven ability to troubleshoot equipment/process issues and support deviation investigations to root cause. /liliLanguage Proficiency: Professional working proficiency in both German and English (written and spoken) is preferred /liliCleanroom Readiness: Comfortable working in classified cleanroom environments (including gowning and physical handling of raw materials). /lili12-month contract opportunity, gaining experience in a leading global biopharmaceutical manufacturing environment. /liliVaried role combining hands-on manufacturing operations in Weigh Dispense and Solution Supply with technical projects, compliance activities, and MES digitization initiatives. /liliProfessional development opportunity to expand expertise in GMP manufacturing, deviation management, quality systems, and cross-functional collaboration within biotech operations.br/ /li /ulh3Contact /h3pQuote job ref: JN- /p /p #J-18808-Ljbffr
Solutions Supply Specialist (a) Arbeitgeber: Michael Page
Unser Mandant ist ein hervorragender Arbeitgeber, der eine moderne Unternehmenskultur mit flachen Hierarchien und kurzen Entscheidungswegen bietet. Die Finanzabteilung spielt eine zentrale Rolle in der Unternehmenssteuerung und ermöglicht den Mitarbeitenden vielfältige Entwicklungsmöglichkeiten in einem internationalen Umfeld. Mit flexiblen Arbeitszeiten, einem attraktiven Gehaltspaket und zahlreichen Corporate Benefits ist das Unternehmen ein idealer Ort für Fachkräfte, die eine sinnstiftende und abwechslungsreiche Tätigkeit suchen.