MES Engineer

SimoTech is looking for an experienced MES Engineer to operate within the MES team in the implementation and maintenance of an MES system for a client site based in Sligo. This role will go to the end of December 2019 with the potential to being extended into 2020.

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 to a high quality standard.
  • 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, 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.
Qualifications
  • 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.
  • 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.
  • Innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
  • Results driven striving to meet all targets and metric standards as set by site/department and division leaders.
  • Total commitment to quality and maintaining a high standard of work at all times.
  • Demonstrates the highest levels of integrity and a strong work ethic at all times.
  • Strong communication skills both verbal and written are required for the execution of this role.
  • Strong interpersonal skills are required.
  • Understands and Supports the principles of Perfect Performance.
What SimoTech Can Offer
  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.
  • Flexible working hours and location.

By submitting my data (C.V.), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech  Privacy Statement which I have read.