Clinical Biotechnician

PSC Biotech Corporation; Cork; On-site; EUR 38,000 - 48,000; Full time

Job summary

PSC Biotech Corporation is hiring a Clinical Biotechnician Specialist on behalf of one of our clients in Cork. Reporting to the Manufacturing Manager, the Biotechnician will perform day-to-day activities within cell culture, purification and process services within Manufacturing.

Reporting to the Manufacturing Manager, the Biotechnician will be responsible for ensuring the site start-up, process validation and product launch activities.

Qualifications

• Bachelor's degree in biotechnology or related field.
• Experience with cGMP and GMP documentation.
• Strong troubleshooting and equipment operation skills.

Responsibilities

• Perform cell culture, purification, or support operations within Manufacturing.
• Monitor process performance using statistical process control.
• Support commissioning and qualification activities.
• Prepare, update and execute Batch Records and SOPs.
• Provide process and equipment related training as required within the Manufacturing Department.
• Lead cross-functional initiatives when needed.

Skills

Cell Culture

Purification

Process Operations

Six Sigma/Lean

Education

Bachelor's degree in Biotechnology or related field

Tools

DeltaV DCS

PLC Systems

Job description

• Industry Pharma/Biotech/Clinical Research
• City Cork
• State/Province Cork
• Country Ireland

Job Description

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.

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

12 Month of Contract

Requirements

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.