Job Type: Perm
Job ID: JO-1908-19280
Consultant: Karen McHugh
Do you have an expert Working knowledge of MES, in particular Werum PAS-X?
Would you like to work for a multinational Biopharmaceutical company based in Dublin?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
MES Process Engineer - Dublin West - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their plant, this is an exciting time to join the team.
Proactively work with relevant Departments and project team members to support the development of MES processes including establishment of EBRs and integration of SAP and Data Historian.
Proactively provide technical support to manufacturing operations in order to ensure that the MES systems are implemented and can be operated and supported to ensure optimum efficiency.
Lead e-MBR authoring & general MES configuration for existing business process.
Lead and support development of requirements analysis/understanding in terms of MES, EBRS, SAP and data historian
Lead and support the development of all necessary project and system support documentation including but not limited to designs, configuration, procedures, testing etc.
Support and assist execution of all stages of qualification (test scripts, validation liaison etc.).
MES vendor liaison (with technical consultants from Werum within the project framework / QPP)
Lead and support feasibility study and field trials where required in relation to MES project.
Lead and support testing, debugging and documentation of same during installation of MES / EBRS systems.
Lead and support the development of integration requirements between MES and SAP.
Lead and support testing of the integration between MES and SAP system at TILGC, scope includes testing, debugging and documentation of same during installation
Develop and maintain standard operating procedures (SOPs) associated with the site MES System.
On going development and execution of training to all identified users to ensure efficient utilisation of MES systems.
Cross train others within the department to level where they are capable of supporting the MES aspects of routine manufacturing operations.
Proactively work with relevant Departments to support the introduction of new processes including MES EBR development.
Available to participate in and support ‘on-call’ and ‘call out’ systems as required.
Quality Systems and GMP
Ensure that all activities for which they have responsibility are carried out in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (EHS) Legislation.
Ensure that all documentation relating to their areas of responsibility are completed in an accurate and timely manner. Such documentation would include (but not be limited to) records required by SOPs, Logbooks as well as EHS records.
Preparation of reports in relation to deviations and/or investigations, as required
Participate fully in any cross functional training initiatives.
Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP, reading, training and assessment.
Other duties as required and directed by the Director, API Manufacturing Technology or other Officer appointed by the Board of Directors.
Third level Science Degree or equivalent
Expert Working knowledge of MES, in particular Werum PAS-X.
Working knowledge of SAP would be beneficial.
Demonstrated written and spoken communication skills
Demonstrated ability to develop written IT processes and procedures
Project management skills and strong Interpersonal and communication skills (written and verbal)
MES/IT applications aptitude
Ability to work independently as well as in a team environment, and the ability to cultivate and maintain positive business relationships, a well motivated self-starter
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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