MES Program Manager

Location Ireland
Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Caitlin Girdwood

Contact email: c.girdwood@panda-int.com
Job ref: 17603
Published: 13 days ago

Currently seeking an experienced Project Manager to provide Project Management support in relation to the deployment of Manufacturing Systems (MES, Historian, LIMS, Network, & Level 2-4 integration) for ongoing IT/OT projects at my Biotech Client’s manufacturing site. This is an exciting & challenging opportunity for the right candidate to support these projects for new innovative Biotech Projects. Even better, interview + offer can happen within the next 2 weeks!

Technical Skillset:

  • PAS-X MES, MBR’s, and Master Data configuration
  • OSI-PI Historian tag integration, Asset Framework, and Event Frames
  • Integration from shop floor equipment to OSI-PI and OSI-PI to PAS-X aligned with ISA S-95 principles
  • Integration between MES and SAP for master data, production dispatch, and production execution
  • IT/OT network topologies and components

Overview:

  • While hands on configuration of the systems above is not required, an understanding of system functionality and business requirements is required to ensure oversight of system status.
  • A basic understanding of IT infrastructure is required including relational databases (Oracle), server/network architecture, and deployment methods for Level 3 Manufacturing Systems
  • Excellent project lifecycle skillset is required through requirements, specification, configuration, verification, and handover to business/quality users.
  • Understanding of Project Management tools and techniques is required, ideally underpinned by a formal Project Management credential

 

Industry Skillset

  • Experience of delivering projects within the Pharmaceutical sector is mandatory, with emphasis on understanding small molecule API, capsule manufacture, and secondary packaging, plus cell therapy Drug Substance and Drug Product manufacture in Aseptic Environments
  • background in GxP environments and practices is required
  • Strong knowledge of GAMP5 good practices and prevailing Data Integrity regulatory guidance is required, especially as applied to Computer Systems Validation and overall compliance.

Project Skillset

  • A minimum of 8 years of project management/leadership in Pharmaceuticals, with exposure to the technical and industry skillsets above is required
  • This is an “embedded” Project Management role reporting to the IT/OT Program Manager.
  • The successful candidate will Manage the project within a core team of 6-12 contract resources (including a Lead Engineer per MES/LIMS/Historian workstream) assigned for the project duration, with support from full time site MES/Automation/Lab Application System Owner representatives and Integrators/Vendors.
  • Collaboration with the broader site team is also critical including IT, Quality, QA Validation, Compliance, Technology Transfer, EHS, & Engineering).

Start Date: ASAP (flexible)

Duration: 12 months (extension likely)

Interested? Get in touch by emailing your CV to c.girdwood@panda-int.com and I’ll get in touch ASAP. Interviews will happen 2nd/3rd week Jan.