Solutions Supply Specialist (a)

Michael Page; Luzern; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Michael Page is seeking a Solution Supply Specialist for an international biotech company in Lucerne area. The role blends technical office work (deviation management, SOP/MES authoring, digitization) with hands-on Weigh & Dispense and buffer/media preparation on the floor.

Start in October for a 12-month contract with extension option. The candidate will manage GMP-compliant documentation, support MES/EBR deployment, lead deviation investigations, and collaborate across functions to ensure

Qualifikationen

• Hands-on manufacturing experience in GMP-regulated biopharmaceutical or pharmaceutical environment (3+ years).
• Experience with paper and electronic batch records (MES/EBR/LIMS/SAP).
• Strong knowledge of GDP and ALCOA+ principles.

Aufgaben

• Quality & document control: authoring and maintaining SOPs, sampling plans, and procedures to GMP/GDocP standards.
• Digitization & MES: onboarding, testing, training, and aligning MES/EBR with paper records to drive digitization.
• Deviation & risk management: lead investigations, assess risk, and drive corrective actions.
• On-the-floor operations in W&D and Solution Supply, including material handling and inventory control.
• Cross-functional collaboration to meet compliance, quality, and technical deliverables.

Kenntnisse

GMP knowledge

GDP/ALCOA+

MES

SOPs

QMS

Ausbildung

Technical vocational training (Biotech/Chemical)

Tools

MES

EBR

LIMS

SAP

Jobbeschreibung

• 12 months contract with extension option
  

• International biotech company
• 12 months contract with extension option
  

About Our Client

For 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 (W&D) and Buffer/Media Preparation. Start in October, for the next 12 months with extension option.

Job Description

Key responsibilities include:

The Successful Applicant

What's on Offer

• Technical Office Work, Compliance & Deviation Management
• 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.
• Cross-Functional Collaboration: Lead and participate daily in cross-functional teams to collaboratively address and cover compliance, quality, and technical deliverables under direction.
• On-the-Floor Operations (W&D & Solution Supply)
• 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.
• EHS Risk Assessments: Lead, facilitate, and participate in EHS risk assessments and site safety initiative implementations on-floor.
• Technical or scientific vocational training (e.g., Biotech/Chemical Laboratory Technician, Chemical Operator, Druggist/Pharmacist Assistant) or equivalent practical experience.
• 3+ years of hands-on manufacturing experience within a GMP-regulated biopharmaceutical or pharmaceutical environment (specifically in solution preparation, formulation, or central services).
• 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.
• Experience operating single-use systems, parts washers, autoclaves, and analytical benchtop instruments (e.g., pH/conductivity meters).
• 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).
• 12-month contract opportunity, gaining experience in a leading global biopharmaceutical manufacturing environment.
• Varied role combining hands-on manufacturing operations in Weigh & Dispense and Solution Supply with technical projects, compliance activities, and MES digitization initiatives.
• Professional development opportunity to expand expertise in GMP manufacturing, deviation management, quality systems, and cross-functional collaboration within biotech operations.
  

Contact

Quote job ref: JN-092026-7096958