Solutions Supply Specialist (a)

Key responsibilities include:

1. 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 escalate 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.

2. 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.