MES Process Engineer

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Job Description

JOB PURPOSE:

The Process Engineer (MES) has a very important role to play in TILGC’s commitment to quality and efficient manufacturing together with the training of people. Specific and varying duties will be given to the Process Engineer (MES) in relation to their current assignment but some key tasks and responsibilities are outlined below. The Process Engineer (MES) will have a particular focus on the Werum MES system and its effective operation with supporting systems.

Key responsibilities will be technical lead to MES related projects along with supporting day to day operations associated with the MES system. A further expectation is the cross training of others to increase MES capability at TILGC.

The engineer and must be capable of working both on their own initiative and as part of a very flexible team in a demanding, regulated environment. They are required to proactively contribute to the delivery of manufacturing targets within quality, safety and environmental requirements and on schedule.

RESPONSIBILITIES:

• Perform duties as directed in whatever area of the active MES Project they may be assigned to. Scope includes but not limited to:
• 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.
• Provide a technical lead to MES project (including EBRS, Data historian and SAP integration) as SME on TIL production process & environment knowledge
• 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)
• Provide timely and accurate information and status updates to functional leaders on project progression (with PM & TIL management 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

General MES Support Activities

• 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

GENERAL RESPONSIBILITIES:

• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
• 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.

EDUCATIONAL REQUIREMENTS:

• Third level Science Degree or equivalent.

RELEVANT EXPERIENCE/CRITERIA:

• 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

Locations

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

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