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AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
We are recruiting a Senior MVI Technician to join our site in Ballytivnan, Sligo. This role will require shift work.
Responsibilities
* To work as a team member to support biologics operations in line with all safety, regulatory and organizational requirements.
* 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.
* 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 as Required.
* Perform final product visual inspection, as required.
* 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.
* Material receipt from warehouse, verifying all pertinent documentation & completion of all relevant transactions on SAP/POMS.
* Completion of Inventory Counts, as required.
* Transfer of final material to warehouse inventory.
* Perform process tests and participate in qualification and validation activities as required.
* Ensure all manufacturing documentation is completed on a timely manner without errors, following cGMP’s.
* 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.
* 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 & primary reviewer for the batch records in development.
Qualifications
* 3rd level qualification in a relevant Science discipline.
* 3+ years experience in a similar position.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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