Clinical Biotechnician

Cork - Ireland

Monthly Salary: Not Disclosed

Experience Required: 4-5years

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

Who are we

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

PSC Biotech is hiring a Clinical Biotechnician Specialist on behalf of one of our clients in Cork.

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

Requirements

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.

#LI-DM2

Required Skills:

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. #LI-DM2

Who are wePSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Man...