I'm seeking two PAS-X MES Engineers to support EBRS rollout to enable manufacturing of:
- Project 1: API and packed Drug Product capsules;
- Project 2: Cell Culture Injectables
This is an exciting & challenging opportunity for the right candidate to contribute from the start to deploying new MES solutions to support manufacturing in new small molecule/aseptic manufacturing facilities.
Interview + offer can happen this week!
Role: Two PAS-X MES Engineer, Small Molecule /Cell Culture (5+ years exp.)
Duration: This is a 12-month contract position starting immediately, with potential for contract extension thereafter.
Location: Commensurate with project dynamics at any point in time, approximately 50% of billable time must be conducted on site. Site time will be lower as required and based on site guidelines for pandemic controls.
- 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 dispensing and master data setup (e.g. equipment,
- materials, state diagrams etc.)
- Experience in Small Molecule manufacturing (API and Drug Product, oral dose) OR in GxP Aseptic Manufacturing is mandatory.
- Experience in PAS-X project implementation is required, especially in the area of MBR design/modification and testing. This experience should be greater than 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.
- In addition to the above scope and skill sets, we may assign other MES project related responsibilities commensurate with the experience and skills of the successful candidate (e.g. supporting go live efforts in terms of setup and hand holding, MES procedure writing, Audit preparation support, assisting with MES hardware setup etc..)