Process Engineer - Solution Supply Specialist
Process Engineer – Solution Supply Specialist – 12 months
(Weigh & Dispense, Buffer & Media Prep). Onsite role.
Role Overview
You will act as a key link between direct floor operations and quality systems, driving continuous improvement, safety, and compliance specifically within W&D and Solution Supply to support our upstream and downstream manufacturing streams.
Key Responsibilities
- Technical Office Work, Compliance & Deviation Management.
• Quality & Document Control: Support the authoring, revision, and maintenance of 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).
• Deviation & Risk Management: Lead, investigate, and escalate deviations occurring within Solution Supply. Act as a Quality Risk Assessment (QRA) and Change Champion.
• 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 requirements.
• Buffer & Media Preparation: Execute routine formulation, sterile filtration, and supply activities to provide critical buffers and media for USP and DSP processing.
• Equipment & Cleanroom Operations: Operate, set up, and prepare process equipment.
• 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.
• Process Sampling: Execute critical process sampling (e.g., pH, conductivity, bioburden).
- Safety, Leadership & Culture
• EHS Risk Assessments: Lead, facilitate, and participate in EHS risk assessments and site safety initiative implementations on-floor.
• Continuous Learning: Help solve complex formulation and process problems.
Job Requirements
• Education: Technical or scientific vocational training (e.g., Biotech/Chemical Laboratory Technician, Chemical Operator, Druggist/Pharmacist Assistant) or equivalent practical experience.
• Experience: Min of 3 years of hands-on manufacturing experience within a GMP-regulated 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 & ALCOA+ principles.
• Equipment Expertise: Experience operating single-use systems, parts washers, autoclaves, and analytical benchtop instruments (e.g., pH/conductivity meters).
• Language Proficiency: Fluency in both German and English (written and spoken) is preferred.
