Beschreibung

In this role, you will be at the heart of manufacturing operations, executing processes in compliance with cGMP guidelines, troubleshooting equipment, and ensuring high-quality standards. Your expertise will also contribute to new projects and staff training, making a significant impact on production efficiency.

Anforderungen

• •Completed chemical/biopharmaceutical education or corresponding training qualification, Bachelor/Master's degree in Biotechnology, Biology, Biochemical Engineering or related disciplines
• •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

• •Execute manufacturing activities in Upstream or Downstream Processing according to cGMP guidelines
• •Evaluate test results and troubleshoot manufacturing equipment
• •Resolve issues and make recommendations for resolution
• •Support preparation of SHE, EM, and risk assessments for assigned products
• •Assist in preparing documents like 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
• •Deliver input for the setup, commissioning, and qualification of manufacturing suites and equipment
• •Train manufacturing staff on specific equipment and standard operations