Pharmaceutical Technology Specialist III

AbbVie

Westport, Ireland

The role of Pharmaceutical Technology Specialist III will report to the Senior Manager of the NPI team as part of the Tech Center function. This role involves performing focused work to provide technical support to the business as well as specific manufacturing process tech transfers (NPIs). The staff will also support day-day operations activities within the NPI function. Other aspects of this role are QMS, Instrument validation, compiling and review of project documentation (e.g., SOPs, methods, Master records, Batch Records, Reports). The candidate will also be coordinating with several departments to holistically develop technical and leadership skills.

Responsibilities will include

Execution of process development on existing products or new late-stage clinical products including scale up to plant equipment;
Work with multiple departments as a part of routine work, especially, QA and validations;
Provide on-the-floor technical support to the Production Team Leaders for process/equipment optimization and troubleshooting;
Provide technical support to all manufacturing and chemistry related issues. Tasks include, daily trouble shooting, optimization, cost reduction, training and coaching of manufacturing personnel;
Support of process front runs/use tests for both NPI and commercial processes;
Development of process control recipes for NPIs and optimization of existing commercial process recipes;
Adhere to and engage in all site Safety rules, programs, and initiatives;
Authoring and reviewing batch records, protocols and reports;
Work in accordance to the AbbVie Ways We Work.

Qualifications

Graduate or post-graduate student in relevant science field with 3+ years of experience in GMP manufacturing;
Experience with aseptic fill-finish is preferable;
Must be a self-starter with the ability to work on own initiative;
Flexibility of working hours may be required, and shift work may be required upon request;
Excellent communication and interpersonal skills for interaction with internal departments (QA, Validation, IS, EHS);
Good time management, organizational and technical writing skills;
Able to work in a fast, dynamic environment whilst being able to adjust readily to meet unexpected constraints.

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