Job Description
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.
Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.
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.
Title: Material Operations Biotechnician
Work Type: 12 months of contract
Location: Cork, Ireland
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 areas of 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
Skills
Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
Education
Bachelor degree in Biotechnology, Chemical or Biochemical Engineering, Biochemistry or Bio-systems Engineering or related field or equivalent experience is preferred.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
