SimoTech requires an MES Engineer for a large-scale biopharmaceutical project in Dublin. Candidates must have at least 3-5 years’ experience working within the biotechnology or pharmaceutical industry.
This role requires 3-5 years’ experience, with a focus on experience from the Bio pharma industry. Ideal candidates will be competent with the use of platforms such as Werum Pas-X, Rockwell Pro-Pack Data, Camstar.
- Performs MES activities to ensure appropriate MES content/development and changes to meet the facility goals of High Product Quality and Lean Manufacturing.
- Create project deliverables such as design documents, configuration, installation and validation activities.
- Gathers input and coordinates with project team to develop project change control requirements.
- Testing and computer system validation of the MES Recipes and related configuration as required by the MES delivery project manager.
- Carry out validation script creation and testing required for each MES recipe to meet site business requirements and specifications.
- Supports the project manager on any documentation development and configuration activity as needed.
- Support MES_RAL to identify and implement changes to support lean, flexible MES systems of work.
- Bachelors or Masters Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- At least 3-5 years’ experience with an MES in the biotechnology or pharmaceutical industries.
- Experience with MES system design, configuration and application of business processes in a biopharmaceutical manufacturing environment would be advantageous.
- Good communication and problem solving skills.
- Proven success working well in a team environment.
- Knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB).
- Experience of Drug Substance upstream and downstream processes would be advantageous.