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DescriptionTeam Horizon is seeking a Biologics Technician for our client based in Sligo. The Biologics Technician will produce biologics product material as per organizational needs in line with all relevant compliance materials. This person will work as a team member to support biologics operations in pharma operations in line with all safety, regulatory, and organizational requirements.
Why you should apply:
* This is an excellent opportunity to join a world-class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
* Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply as they expand internationally.
What you will be doing:
* Operate different equipment in daily production operations.
* Document all activities in line with cGMP requirements.
* Efficiently operate all biologics processes minimizing material loss.
* 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 Lyophilizer, as applicable.
* Perform sanitation and cleaning of all relevant equipment and areas.
* Perform final product visual inspection and product intermediary packaging, as applicable.
* Assemble and inspect equipment in the manufacturing area to confirm operational status and perform all in-process testing methods.
* Monitor process alarms.
* Receive materials from warehouse, verifying documentation and transferring final material to warehouse inventory.
* Perform process tests and participate in qualification and validation activities as required.
* Diagnose and resolve events or exceptions of production equipment and processes.
* Dispose of domestic, biomedical, and hazardous waste following regulations and procedures.
* Keep detailed records of operations during the work shift.
* Participate in Factory Acceptance testing, Site Acceptance Testing, and commissioning and qualification of equipment.
* Ensure successful external inspections, and Division and Corporate audits.
* Contribute to the development of batch records and electronic batch records for the site.
* Perform other duties as assigned.
What you need to apply:
* Irish Leaving Certificate or equivalent.
* 1 year of experience in Batch processing operations in an FDA/HPRA regulated industry is highly desirable.
* Good knowledge of cGMP and regulatory requirements related to the biologics/pharmaceutical industry is desirable.
* Experience operating in a highly automated environment and handling dangerous chemicals safely is highly desirable.
* Possessing aseptic techniques and sterile fill experience is an advantage for operators assigned to Fill Finish.
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