SKILLS BRIEF

• Experience in an IT/Software focused role in a GMP (Pharma, Life Sciences, Medical Devices, Biotech) manufacturing environment is essential and only candidates with some experience in this area will be considered.
• Working knowledge of drug product manufacturing and packaging in pharmaceutical/biotech industries or aseptic processing.
• MES experience (Preferably Werum PAS|X) with focus on workflow, S95 & S88 standards and integration from the control layer to MES in pharma & bio-pharma industries
• Knowledge of regulation requirements (including cGMP, 21CFR Part11)
• Knowledge of Quality Systems (e.g. Veeva Vault, NC/CAPA)
• Knowledge of validation processes and understanding of validation protocol generation requirements
• Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, SCADA, PLC, Historian)
• Strong capabilities in S95 level 2 and level 3 systems and their integration

THE ROLE

• MES Integration Engineer
• Dublin
• Hybrid role – you will be expected to be onsite in South Dublin typically 3 or 4 days per week so you must be able to commute to site as required
• Permanent or Contractor opportunity

ROLE BRIEF

This role will be responsible for the delivery of new and updated integration functionalities for Manufacturing Information Systems for use in production.

Core Responsibilities:

• Development, configuration and testing for integration components of Master Batch Records (MBRs) from initial to final design
• Leading integration development design reviews including liaising with Automation, Operations, Process Development, Validation and Quality functions
• Equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment and lab equipment for in-process testing
• Liaising with Plant Support, System Owner and Operations teams regarding documentation changes in an effective and timely manner
• Responsible for the MBR design oversight, support and ongoing development of the client site MES system
• Training of Electronic Batch Record (EBR) designers and end-users on MES integration activities and development of job aids
• Support and assist in fast Manufacturing Execution System (MES) issue resolution where required and as directed by Operations leadership
• Development, review and update MES Standard Operating Procedures and Design Specifications
• Contribute to extending our MES solution and developing project & technical skillset in collaboration with our team and Vendor consultants.