Overview
Senior Biologics Technician role at AbbVie, based in Ballytivnan, Sligo. The role involves shift work and supports biologics operations in compliance with safety, regulatory and organizational requirements.
Responsibilities
* Work as a team member to support biologics operations in line with safety, regulatory and organizational requirements.
* Provide support on change controls, investigations, tasks and CAPAs for the Biologics Operations Department.
* Support the Operations Lead in safety, regulatory and organizational requirements when delegated.
* Coordinate between shift teams to ensure excellence in GMP, safety and manufacturing activities.
* Act as Point of Contact for Manufacturing issues and escalate to Supervisor as required.
* Operate biologics processes efficiently to minimize material loss.
* Operate Fill Line, Autoclave, Equipment Washer, Headspace Analyzer, Filtration Systems, Cleaning and Sterilization equipment, Pressure Tests, Integrity Tests, Water Baths, Isolators and Lyophiliser as applicable.
* Perform Operations Batch Review as required; conduct final product visual inspection and intermediary packaging as applicable.
* Assemble and inspect equipment to confirm operational status; perform in-process testing methods.
* Handle material receipt from warehouse, verify pertinent documentation and complete transactions in SAP/POMS; participate in inventory counts and transfer final material to warehouse inventory.
* Participate in process tests and qualification/validation activities; ensure timely, accurate manufacturing documentation following cGMPs.
* Diagnose and resolve events or exceptions of production equipment and processes; dispose of waste per regulations.
* Maintain detailed records of shift operations; participate in Factory Acceptance Testing, Site Acceptance Testing and commissioning/qualification of equipment.
* Adhere to all relevant Quality & Safety policies and support external inspections and audits.
* Contribute to development of batch records and electronic batch records; act as primary reviewer for batch records in development.
Qualifications
* 3rd level qualification in a relevant Science discipline.
* 3+ years of experience in a biologics position.
Additional Information
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.
US & Puerto Rico only – learn more about equal employment opportunities at AbbVie.
Applicants seeking a reasonable accommodation: visit the AbbVie accommodation page.
Location
Ballytivnan, Sligo, Ireland
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