Senior Biologics Technician


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https://www.teamhorizon.ie/1079-senior-biologics-technician/operations-manufacturing/sligo/job2023-10-26 12:53:231970-01-01Team Horizon
Job TypePermanent
AreaSligo, IrelandSligoIreland
SectorOperations & ManufacturingRegulatory
Start Date
AdvertiserAshling Guthrie
Telephone+353 1 574 4006
Job Ref3077
Job Views680
Description

Team Horizon is seeking an experienced Senior Biologics Technician to join our clients’ site in Sligo. The Senior Biologic’s Technician 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 of our medicines as they expand internationally.


What you will be doing:



  • Provide support on change controls, investigations, tasks and CAPAs for the Biologics Operations Department.

  • To support the Operations Lead in line with safety, regulatory and organisational requirements when delegated responsibility.

  • Co-ordination between shift teams to ensure excellence in GMP/ safety and manufacturing activities

  • Point of Contact for Manufacturing issues which arise and if escalation to Supervisor is required.

  • Promote compliance with Aseptic Practices and cGMP

  • Documentation of all activities in line with cGMP requirements.

  • Efficiently operate all biologics processes minimizing material loss.

  • Operate Fill Line, Autoclave, Equipment Washer, Headspace Analyzer, Filtration Systems, Equipment Cleaning and Sterilization,

  • Equipment Pressure Tests, Equipment/Filters Integrity Tests, Water Baths, Isolators and Lyophiliser, as applicable.

  • Perform Operations Batch Review, final product visual inspection, as required product intermediary packaging, as required.

  • Assemble and inspect equipment in the manufacturing area to confirm its operational status.

  • Material receipt from warehouse, verifying all pertinent documentation & completion of all relevant transactions on SAP/POMS

  • Diagnose and resolve events or exceptions of production equipment and processes.


What you need to apply:



  • Irish Leaving Certificate or equivalent. Certificate/Degree in relevant Science/ Engineering /Manufacturing discipline is desirable.

  • Minimum of 3 years in Batch processing operations in an FDA/ HPRA regulated industry is essential.

  • Possessing minimum of 3 years’ experience using aseptic techniques and sterile fill experience is essential.

  • 3 years plus of Knowledge of cGMP and regulatory requirements relating to the pharma/biologics industry.

  • Experience of operating in a highly automated environment and safe handling of dangerous chemicals is highly desirable.

  • 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.

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