Job Description
Design, create, write and execute MES recipes, worksheets, equipment and material specs, including phase transition logic. Provide technical guidance and solutioning to MES Engineers. Act as site escalation point for complex troubleshooting or recipe design. Provide project management guidance to MES function. Design, create, write and execute protocols, risk assessments, and system documentation. Ensure cleaning, equipment and product procedures align to MES processes and vice versa. Design, create, write and provide training on MES roles and arrange system access. Participate in MES knowledge exchanges, governance meetings, and manage issues, work-arounds and fixes. Liaise with Global MES on required system improvements. Provide support to MES system users to ensure business continuity. Participate in NPI projects to ensure MES system or hardware requirements are considered. Keep recipe authors up to date on MES changes. Participate in continuous improvement programs to implement quality, safety, environmental and production improvements. Adhere to and support EHS standards, procedures and policies. Requirements include a Third Level qualification, a minimum of 2-5 years authoring experience, proficiency in MES application and configuration rules, experience in batch processing operations in a regulated industry, and knowledge of cGMP and regulatory requirements. Proven attention to detail and mental concentration are required to ensure total compliance with procedures.
**Key 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
**Requirements:**
* Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience
* A minimum of 2-5 years authoring experience and has led or was technical lead on multiple implementation projects
* Be proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet)
* 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