Manufacturing Operations Specialist
Vor 4 Tagen
We are seeking a highly skilled Manufacturing Operations Specialist to join our team at Lonza. As a key member of our operations team, you will be responsible for executing operational activities of assigned manufacturing projects in specific areas (Up-stream or Down-stream processing).
Key Responsibilities- Manufacturing Execution: Execute manufacturing activities in either the Upstream Processing or Down-stream Processing area according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution.
- Safety and Quality: Support the preparation of SHE (Safety, Health, environment), EM (Environmental Monitoring), operation and cleaning risk assessment for the assigned products and the implementation and control of defined measures.
- Documentation and Compliance: Assist document preparation (e.g. electronic batch records, SOPs) specific to the assigned production area, review production documentation and work on deviations, change requests and implementation of CAPAs to ensure high-quality GMP standards.
- Training and Development: Engage in Capital investment projects for building and commissioning of new manufacturing units as manufacturing expert, responsible for delivering all input required for the specific set-up, commissioning and qualification of the manufacturing suites and equipment, and responsible for the training of the manufacturing staff on specific equipment or standard operations.
- Education: Completed chemical / biopharmaceutical education or corresponding training qualification, Bachelor / Master's degree in Biotechnology, Biology, Biochemical Engineering or related disciplines is an advantage.
- Knowledge and Skills: Sound knowledge of biotechnological processes either in the area of microbial and/or mammalian cultivation or in the area protein purification, excellent communication skills, team player, driven and solution-oriented.
- Language: Fluency in English required, fluency in German is considered a plus.
- Work Schedule: Open to work in shift (4-shift system).
- Additional Requirements: Basic GMP understanding is a plus.
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