Our client needs a need a MES Technical lead to support POMSnet system upgrade and recipe authoring.
Need to provide oversight and mentorship to a team of internal and external recipe authors, with authors focused on new recipe development. Consultant Acting as the bridge between SAP and POMSnet, translating SME business processes into executable MES logic. Also, Working closely with operators to deliver training and ensure smooth deployment. Provides technical leadership, independent system configuration, and ownership of MES recipe deliverables.
Purpose
* Maintain the MES (POMSnet) environment; to author and maintain recipes and worksheets for the Westport site.
* Provide technical guidance and solutioning to other MES Engineers.
* Act as site escalation point for complex or challenging troubleshooting or recipe design.
* Provide project management guidance and expertise to the MES function.
* Performing recipe configuration, template setup, dry runs, troubleshooting, and on-site production support.
Responsibilities
* Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic
* Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
* Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
* Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
* Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified.
Requirements
* Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
* A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.
* Need POMSnet experience .Be proficient with MES application and configuration rules and requirements including interfacing
* Requires strong POMSnet expertise plus SQL and C# knowledge.
* Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
* A good knowledge of IT systems is required for this role.
* SAP knowledge/experience in MM, PP and IM modules.
* Proven attention to detail and mental concentration, to always ensure total compliance with procedures.