Job Descriptions

A snapshot of your key responsibilities as a Biologics Technician would be:

• Efficiently operate all biologics processes minimizing material loss.
• Documentation of all activities in line with cGMP requirements.
• Operate Fill Line, Autoclave, Equipment Washer, Headspace Analyzer, Bioreactors, Chromatography Columns, Filtration Systems, Equipment Cleaning and Sterilization, Equipment Pressure Tests, Equipment/Filters Integrity Tests, Water Baths, Isolators and Lyophiliser, as able.
• Perform final product visual inspection.
• Perform product intermediary packaging, as applicable.
• Perform all in process testing methods.
• Material receipt from warehouse, verifying all pertinent documentation.
• Perform process tests and participate in qualification and validation activities as required.
• Diagnose and resolve events or exceptions of production equipment and processes.
• Disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations, following the procedures and policies of the plant, division, and the corporation.
• Keep detailed records, manual or electronic, of the operations carried out during the work shift.
• Adhering to all relevant policies relating to Quality & Safety.
• Work with Engineering, Quality and other departments in the development and update of Standard Operating Procedures.

Education and Experience

• Irish Leaving Certificate or equivalent
• 1 year in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable
• A good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable
• Basic laboratory techniques knowledge.
• Experience of operating in a highly automated environment and safe handling of dangerous chemicals is highly desirable.
• Possessing aseptic techniques and sterile fill experience is a distinct advantage for operators assigned to Fill Finish.
• Good I.T. skills are required
• Strong communication skills both verbal and written are required for the execution of this role.
• Demonstrates the highest levels of integrity and a strong work ethic at all times

Skills

• IT Skills
• Good communication skills

Experience

• 1 year