Beschreibung

In this role, you will be at the heart of manufacturing operations, ensuring compliance with cGMP guidelines while managing both upstream and downstream processes. Your day-to-day responsibilities will include troubleshooting equipment, preparing essential documentation, and training staff, all while contributing to new capital projects.

Anforderungen

• •Completed chemical/biopharmaceutical education or corresponding training qualification, Bachelor/Master's degree or equivalent experience in Biotechnology, Biology, Biochemical Engineering or related fields
• •Sound knowledge of biotechnological processes in microbial and/or mammalian cultivation or protein purification
• •Excellent communication skills, teamwork, driven and solution-oriented
• •Fluency in English, fluency in German is a plus
• •Openness to work in shift (4-shift system)
• •Basic GMP understanding is a plus

Aufgaben

• •Perform operational activities for assigned manufacturing projects
• •Complete manufacturing activities in Upstream or Downstream Processing
• •Ensure batch execution according to cGMP guidelines
• •Evaluate test results and troubleshoot manufacturing equipment
• •Resolve issues and recommend solutions
• •Support preparation of SHE, EM, and risk assessments for assigned products
• •Assist in document preparation, including electronic batch records and SOPs
• •Review production documentation and address deviations and change requests
• •Implement CAPAs to maintain high-quality GMP standards
• •Engage in capital investment projects for new manufacturing units
• •Provide input for the setup, commissioning, and qualification of manufacturing suites
• •Train manufacturing staff on specific equipment and standard operations