Job Description
An amazing opportunity has arisen for an Operations Production Associate Specialist within our R&D facility at our new state-of-the art facility in Dunboyne.
Our R&D facility at Dunboyne will be a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.
Our Dunboyne facilities serve as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in Dunboyne, but that the facility belongs to and is shaped by them.
What You Will Do
Bring energy, knowledge, innovation and leadership to carry out the following:
* Drug Support Process Operations point of contact for COMET.
* Monitor the SAP system to ensure optimal performance and proactively identify potential issues.
* Collaborate with Super Users for business support and closure of COMET/MES errors. Collaborate with the Global and local teams to implement system enhancements and upgrades and take part in global CoP.
* Provide support to the Manufacturing team to resolve any issues in a timely manner.
* Training and Compliance: Provide training and support to production personnel on SAP and other systems functionalities, production processes, and compliance with standard operating procedures, health and safety protocols.
* Collaborate with SAP/GLIMs superusers and support with builds/upgrades coming from NPI.
* Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop support weekend or on-call duty on select time frames to support manufacturing.
What Education, Experience And Skills You Will Need
In order to excel in this role, you will need:
* 3 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate. Proficient in SAP modules such as Production Execution (PE), Material Handling (MH), and Materials Management (MM) to effectively manage production processes within the pharmaceutical industry.
* Experience working in a GMP/regulated environment with an understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
* Analytical and Problem-solving Skills: Ability to analyse complex production data, identify process gaps, and propose effective solutions to streamline operations and enhance productivity.
* Communication and Teamwork: Excellent communication skills to liaise with cross-functional teams - Experience in resolving production-related issues, and foster collaboration across different departments.
* Proficient in SAP COMET
* Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
* Knowledge of GLIMs desirable Problem, Deviation, and Change Management experience.
Employee Status
Regular
Requisition ID:R332006 #J-18808-Ljbffr