Senior MES Engineer

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Senior engineer designing, configuring, and supporting MES systems for pharma.
11 days ago ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
Westport, County Mayo, Ireland
Onsite
Role
What you would be doing
mes recipes
validation protocols
mes governance
npi support
ehs compliance
mes training
  • 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/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
  • Documentation of all activities in line with cGMP requirements.
  • 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-around and fixes identified.
  • Adheres to and supports all EHS standards, procedures and policies.
  • Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
  • Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
  • Keep other recipe authors up to date on MES changes
  • Cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
  • Provide support to other MES system users as required to ensure business continuity.
What you bring
mes
pomsnet
sap
technical lead
cgmp
degree
  • Be proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
  • Extensive authoring experience and has led or was technical lead on multiple implementation projects.
  • SAP knowledge/experience in MM, PP and IM modules.
  • Proven attention to detail and mental concentration, to always ensure total compliance with procedures.
  • 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.
  • Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
Benefits
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Training + Development
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Senior MES Engineer at Qcs Staffing in Westport, County Mayo, Ireland