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BioMarin are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
Job Responsibility:
Performing, monitoring and troubleshooting of the cell culture, purification or support operations within Manufacturing
Monitoring and reporting of process performance using statistical process control
Support of Commissioning and Qualification activities
Preparation, updating and execution of Batch Records, SOPs and other GMP documentation
Provide process and equipment related training as required within the Manufacturing Department
Troubleshooting of process specific equipment
Troubleshooting of DCS (e.g. Delta V) and PLC control systems
Authoring, investigating and resolving quality deviations raised within the Manufacturing Department
Participate in/ Lead Cross Functional team initiatives when required
Participate in the execution of validation protocols
Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
Completion of assigned tasks to support manufacture of quality biopharmaceuticals in accordance with cGMP and EHS requirements
Use Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence
Working flexible shift patterns to meet business needs and Manufacturing schedule
Requirements:
Bachelor degree in Biotechnology, Chemical or Biochemical Engineering, Biochemistry or Bio-systems Engineering or related field or equivalent experience is preferred
Proficient in the operation of all equipment used in the respective functional area of responsibility
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