Biologics Technician
Our client is looking to hire Biologic Technicians to support the operations function of a new state-of-the-art aseptic fill finish site in Sligo. This client is a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader.
Key responsibilities:
- 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
- 1 to 3 year in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable
- Possessing aseptic techniques and sterile fill experience is essential.
- A good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable
- Good I.T. skills are required
- Strong communication skills both verbal and written are required for the execution of this role.
Competitive package available for this permanent role as well as the opportunity to work with an employee orientated company who offer great career developmental prospects and have a reputation as being a Great Place to Work!
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For a confidential discussion and more information on the role, please contact Davin Ferguson