Senior Biologics Technician
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Job Type | Permanent |
Area | Sligo, Ireland |
Sector | Operations & ManufacturingRegulatory |
Start Date | |
Advertiser | Ashling Guthrie |
Telephone | +353 1 574 4006 |
Job Ref | 3077 |
Job Views | 680 |
- 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.