- Manage delivery of all PI data historian, MES, and Infobatch reporting systems' scope and deliverables for the project.
- Develop and Maintain appropriate reporting tools for IT/Automation Work Package Owner to ensure project schedule, cost, and scope for above systems remain on track.
- Direct vendors and other internal technical resources as applicable to ensure timely completion of deliverables.
- Establish communication pathways and meeting structures with vendors and stakeholders as necessary to drive delivery of project scope.
- Revise and Maintain current project plan and schedule for applicable systems throughout project.
- Work with CSV resources to develop Validation Project Plans for applicable systems, providing technical insight when necessary.
- Provide solutions to technical challenges as they arise and provide technical evluations, when necessary.
- Develop understanding of technical details involved with the systems in scope to facilitate problem-solving efforts.
- Coordinate and collaborate with site SME's and end users to obtain necessary buy in.
- Comment/challenge and coordinate review of design documentation.
- 5+ years' experience as Lead Automation Engineer or equivalent in working with automation in large pharma / biotech projects.
- Experience in Project Management in pharma/biotech projects (PMP certification is an advantage)
- Experience with DCS systems, preferably Emerson's Delta V system.
- Solid process understanding combined with automation understanding
- Experience with MES systems, PI systems, and Infobatch software preferred
- Knowledge of batch processes, GMP, GAMP and the S88 standard.
