We are seeking an experienced PAS-X MES Engineer / MBR (Master Batch Record) Author for MES configuration and project rollout to support manufacturing for new product streams in small molecule API and Cell Therapy production plants. This is an exciting & challenging opportunity for the right candidate to contribute to extending our MES solution, both giving of their experience but also growing and developing their project & technical skillset in collaboration with our team and Vendor consultants. i. Role: Senior PAS-X MBR Author (contract) ii.
Duration: This is a 12-month contract position starting in July 2021, with potential for contract extension thereafter.
Location: Billable time will be a combination of off-site and on-site presence. A guidance, 50% of time may be off site, but this is subject to variation depending on project dynamics, and the candidate must be flexible to be on site by exception as required.
Remuneration: This is a contract role. Payment will be based on an hourly/daily rate for hours worked, invoiced at the end of each month. The rate offered will be commensurate with the experience, skill-set, and suitability of the candidate for the role and in consideration of current market rates.
- The primary technical skillset is Business Analysis and Werum PAS-X v3.1.7 (or similar version) MBR design and development with strong project experience in working closely with Lead Engineers and Process Subject Matter Experts on specification and parameterisation of MBR’s
- Experience in broader PAS-X functionality is beneficial including for example equipment management, materials management/warehouse functionality, state diagrams etc.
- Experience in integration between MES and ISA Level 2 systems (automation systems & equipment) is beneficial
- Experience in integration between MES and OSI-PI historian is beneficial
- Experience in integration between MES and ISA Level 4 systems (SAP) is beneficial
- As the role may involve contribution to MBR development in both small molecule and cell culture plants, broad manufacturing experience is an advantage for this position.
- Experience in sterile/aseptic manufacturing environments is necessary, and experience in in cell culture regenerative medicine is an advantage for this position.
- Experience in small molecule API production including Weighing/Dispensing, Material Tracking, and Production Execution in high containment environments is necessary
- Experience in MES design and configuration (MBR Authoring) from scratch should be greater than 5 years, depending on the relevance of the experience
- The ideal candidate will take a senior role in MBR design, development, and tweaking to completion for identified parts of the production process in the green field facility, so experience in engaging in MES/MBR specification analysis for new production processes and equipment is desirable.
- Documentation of system configuration (Configuration Specifications) following a project template will be a requirement of the role, so strong documentation skills are required in terms of content, language, formatting, and attention to detail
- MES validation test design and execution experience is required based on GAMP5 good practices, as the role will include support for test protocol documentation and execution as the solution approaches go-live stage
- A good understanding of good practice project lifecycles is required through requirements, specification, configuration, verification, and handover to business/quality users. Throughout the life cycle, team engagement, verbal communication, functional requirements & design documentation, validation support, and strong interpersonal skills will be required
- 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 and working closely with an MES Workstream Lead. Other team members include the Validation, QA, local MES Administrators, IS/IT, Systems integrators, Solution Vendors, Process engineers/SME’s, and Management Stakeholders. g. In addition to the technical aspects, exceptional interpersonal skills are required in terms of verbal engagement style, written communications, and proactive issue reporting and escalation
Interested? Get in touch ASAP by sending your CV to firstname.lastname@example.org or call +31202044502 to discuss further!