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Biologics Process Specialist
2 weeks ago
We are seeking a highly skilled Biologics Process Specialist to join our team. This key role will play a pivotal part in the commissioning, start-up, and operation of single-use skid systems and biologics processes.
Key Responsibilities- Assist with factory acceptance tests, commissioning, IQ/OQ, and operational qualification (OQ) of single-use skids and biologics process assets.
- Support plant start-up efforts and act as liaison with suppliers throughout the project lifecycle.
- Collaborate closely with automation, QA/validation, MSAT, and HSE teams—especially in safety assessments, HAZOP reviews, and process risk frameworks.
- Provide hands-on support for commissioning and early manufacturing, supporting troubleshooting, deviations, CAPA, and technical change controls.
- Bachelor's or Master's degree in Biological, Chemical, or Process Engineering, or related disciplines.
- Experience in biologics manufacturing, particularly upstream processing, is highly desirable.
- Familiarity with single-use systems/skids is a strong advantage.
- Prior exposure to manufacturing or MSAT roles, including technology, is beneficial.