Biotechnician

BioMarin Pharmaceutical Inc.; Cork; Hybrid; EUR 40,000 - 60,000; Full time

Job summary

BioMarin is seeking a Biotechnician for a 12-month contract at its Shanbally site in Cork. Reporting to the Manufacturing Manager, the role covers Cell Culture, Purification, and Process Services within Manufacturing, supporting site start-up, process validation, and product launch activities.

You will perform operations, monitor process performance, contribute to CQAs, and ensure compliance with cGMP and EHS requirements, while applying Right First Time and lean practices.

Qualifications

• Proficiency in the operation of all equipment used in the respective functional area of responsibility.

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 and PLC control systems.
• Authoring, investigating, and resolving quality deviations raised within the Manufacturing Department.
• Participate in/Lead Cross Functional team initiatives when required.
• 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

Equipment operation

Education

Bachelor’s degree in biotechnology/engineering/biochemistry

Job description

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-siteshift 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 theBiotechnicianis 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, Chemical or Biochemical Engineering, Biochemistry, Bio-systems Engineering, or related field (or equivalent experience) is preferred.

Contact

Work closely with Process Development, Manufacturing Science Group, Quality Operations, Facility Services and Manufacturing personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.

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.

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.

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