Biotechnician
- Location
- Cork, Ireland
- Work model
- On-Site
- Level
- Mid
- H-1B history
- 10 approvals (FY2023)
About this role
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Position
Biotechnician – 12 Month Contract Location: Shanbally, Ringaskiddy, Cork Type: On-site shift role Shift Details: 4-cycle shift pattern: 2 days, 2 nights, followed by 4 days off About BioMarin: BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and scaling production for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure regulatory compliance, and coordinate the worldwide movement of our drugs to patients.
Role
Overview: Reporting to the relevant Manufacturing Manager, the primary role of the Biotechnician is to perform day-to-day activities within Cell Culture, Purification, and Process Services within the Manufacturing Group. They will be responsible for ensuring the manufacturing team has a successful site start-up, process validation, and product launch activities.
Main Responsibilities
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 .
Skills
Proficiency in the operation of all equipment used in the respective functional area of responsibility. Education: bachelor’s degree in biotechnology,