AbbVie Manufacturing Execution System (MES) Specialist in Sligo, Ireland
At AbbVie, we have the expertise and structure of a proven pharmaceutical leader, and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today—a company that has the ability to discover and reach all corners of the globe with treatment options that can improve people’s lives.
We are currently sourcing aMES Specialistto join our Drug Product Operations team based on our Manorhamilton Road site in Sligo. At this site, we recently underwent a significant €85 million expansion that doubled our site footprint and provided additional capability to support AbbVie’ s new product introductions while delivering on AbbVie’ s potent active pharmaceutical ingredient (API) and drug product manufacturing.
In the role of MES Specialist , you will manage and implement our manufacturing execution system (MES – POMSnet) changes and recipes to align with business objectives.
- Establish with the API Manufacturing Manager the MES team goals, project plans and maintenance schedules
- Lead MES Technicians as required by the API Manufacturing Manager
- Continuously review and manage business risk associated with MES system and recipes
- Continuously review and ensure all business processes, including SOPs, documented policies, procedures and training plans required to implement and manage MES system changes and MES recipe changes are in compliance with relevant systems
- Ensure the timely and compliant validation and qualification of MES recipes and upgrades aligned with business objectives
- Support SAP business system as local key user for MES and material queries
- Accountable to ensure to ensure that all MES related actions, CAPAs and projects are delivered on time, right first time as reflected by site performance targets.
- Responsible for systems compliance with quality related SOP’s
- Act as site representative for audits by HPRA/FDA or Customers on MES.
- Participate in GMES Technical Review Board (TRB) Meetings, and manage issues, workarounds and fixes identified.
- Participate in projects from initiation to ensure MES system or hardware requirements are understood and taken into consideration.
Education & Experience: * Degree in relevant engineering, science or related discipline * 1 year relevant MES experience * A minimum of three years’ experience in an FDA/ HPRA regulated industry * A strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role * Experience of operating in a team environment with active participation in proactive improvement programs is required
Job Classification: Experienced
Job: INFORMATION TECHNOLOGY
Primary Location: Ireland-Connaught-Sligo
Req ID: 1704801