MES Engineer

SimoTech requires an MES Engineer for a large-scale biopharmaceutical project in Sligo. Candidates must have at minimum of 2 years’ experience in Batch processing operations in an FDA/ HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.

Key Responsibilities
  • Troubleshoot and provide solutions for MES & SAP problems in recipe execution and recipe authoring.
  • Liaise with QA to provide approved change control documentation for all MES system changes.
  • Design, create, write and execute to a high-quality standard, test and validation protocols, risk assessments, and system documentation.
  • Design, create, write and/or make all required changes to MES & SAP 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 (CIs, CIRs, MIs, MIRs and SOPs) 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, GMES Technical Review Board (TRB) Meetings, and manage issues, work-around and fixes identified.
  • Work closely with IT regarding upgrades, patching, hardware support, security and system access.
  • Provide support to other MES system users as required to ensure business continuity.
  • Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
  • Ensure maintenance/replacement of MES hardware, scanners and bar-code labelers. Review for upgrades periodically.
  • Keep other recipe authors up to date on MES changes.
  • Documentation of all activities in line with cGMP requirements.
  • 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.
  • Adheres to and supports all EHS & E standards, procedures and policies.
  • May be required have input to Cross Functional Teams and cost improvement projects.
  • Provide technical leadership to functional areas and collaborates with key stakeholders on MES.
Requirements
  • Diploma qualification in suitable science/engineering course and/or suitable experience.
  • A minimum of 2 years’ experience in Batch processing operations in an FDA/ HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.
  • Experience in the operating in a highly automated environment and safe handling of dangerous chemicals is required for this role.
  • A good knowledge of IT systems/MES (preferably POMSnet) is required for this role.
  • A high level of attention to detail and mental concentration, to ensure total compliance with procedures at all times.
  • Proven problem-solving skills, and the ability to adapt to new manufacturing process on a regular basis.
  • Proven technical skills, to ensure the person can cope with the technical demands of the position at all times.
  • Strong communication skills both verbal and written are required for the execution of this role.
  • Understands and Supports the principles of Perfect Performance.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.