I’m seeking a PAS-X MES Engineer to support EBRS rollout to enable manufacturing of Cell Culture injectables for my client in Ireland. This is an opportunity to work with cutting edge technology, and be part of an experienced MES team to develop your skills rapidly.
Ideal if you can visit site 1-2 times per month, but 100% remote is an option! Initial contract until end March with extension for 12 months thereafter.
Interview + offer will happen this week so get in touch ASAP today if interested.
- The primary technical skillset is Werum PAS-X v3.1.7/8 (or similar version) MBR design
- Experience in broader PAS-X functionality is beneficial including master data setup (e.g. equipment, materials, state diagrams etc.)
- Experience in GxP Manufacturing is mandatory. Experience of cell culture manufacturing is an advantage.
- Experience in PAS-X project implementation is required, especially in the area of MBR design/modification and testing. This experience should be minimum 3 years, but ideally 5+ years, depending on the relevance of the experience.
- MES validation test design and execution experience is required based on GAMP5 good practices and GxP regulations, as the role will include support for test protocol documentation creation and execution as the solution approaches go-live stage.
- Documentation of system configuration following a project template will be a requirement of the role, so good GxP documentation skills are required in terms of content, language, formatting, and attention to detail
- Very strong interpersonal skills are required in terms of verbal & written communication style, and a positive, enthusiastic and proactive attitude. Experience in communicating with remote team members to get site tasks complete.
- Experience of training and supporting end users is desirable
- The nature of the role is that the person will be embedded in the project team for the duration of the contract, reporting to a Project Manager/Lead. Other team members include the Validation, QA, local MES Administrators, IS/IT, Systems integrators, Solution Vendors, Process engineers/SME’s, and Management Stakeholders.