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Recognition for your commitment & hard work? We offer that too
Welcome to AbbVie!
At AbbVie, our strength lies in our team of experts who conduct ground breaking science on a global scale every day. At our site in Ballytivnan, we are expanding our facility into a multi-million dollar state of the art biologics plant that will bring ground breaking scientific research to real life solutions for our patients.
We are currently sourcing Biologics Technicans to join our operations team that is responsible for the manufacture of our biologics products in a safe, quality focused enviroment.
Here is a snapshot of your day to day responsibilities:
- Daily production operations operating different equipment while documenting all activities in line with cGMP requirements.
- Efficiently operating all biologics processes minimizing material loss - 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, Headspace Analyser, as applicable.
- Perform final product visual inspection and perform product intermediary packaging, as applicable.
- Assemble and inspect equipment in the manufacturing area to confirm its operational status.
- Perform all in process testing methods and monitor Process Alarms.
- Material receipt from warehouse, verifying all pertinent documentation and transfer of final material to warehouse inventory.
- 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.
- Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
- Adhering to all relevant policies relating to Quality & Safety.
- Ensure successful external inspections, and Division and Corporate audits.
- Active participant in the development of batch records and electronic batch records for the site.
- Work with Engineering, Quality and other departments in the development and update of Standard Operating Procedures.
So what education & experience do you need?
- You will have Irish Leaving Certificate or equivalent with manufacturing experience (3rd level qualification is preferred)
- 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.
- Experience of operating in a highly automated environment and safe handling of dangerous chemicals is highly desirable.
- Good I.T. skills are required
- Possessing aseptic techniques and sterile fill experience is a distinct advantage for operators assigned to Fill Finish
- Requires proven problem solving skills and ability to troubleshoot
So does this sound like the right next career move for you? then come and join AbbVie!
Job Type: Experienced