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
1. 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.

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 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).

3. 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.
Employment Type : Full Time
Experience: years
Vacancy: 1