MES Application Engineer

About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .

Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

• This position is Hybrid from the Killorglin, County Kerry facility.
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Working Hours

• This is a permanent, full-time position.

Purpose and Scope The MES Application Engineer is responsible for the functional management, change management and partly technical management of the business application for Pas-X MES from Korber. Also, will work closely with Pas-X project rollout team to other areas.

Role and Responsibilities

• Key point of contact with the Business Units where Pas-X MES is implemented.
• Provides support to the key users (KU) by co-coordinating change requests; issue resolution and training support as required.
• eMBR design and modeling.
• Set up and maintain all User access profiles and security requirements. Perform periodic reviews of user access, audit trails, system as required.
• Key point of contact to Korber and other 3rd party support vendors.
• Ensure the application is maintained in a validated state as per GAMP requirements and performs to an agreed performance level.
• The MES Application Engineer is a key Subject Matter Expert (SME) for Internal and External audits.
• Maintain and understand the Astellas system in relation to the interfaces with other applications and equipment.
• Develop project plans for small projects or work closely with PTG for major upgrades.
• Support KU with definition of User Requirement Specification (URS), business case and risk assessment.
• Ensure all changes are adequately tested as per approved procedures.
• Investigate opportunities for process optimisations, without introducing customisations within the system.
• Co-ordination of new Astellas and supplier releases.
• Application configuration management.
• Change management.
• Solve incidents and problems in conjunction with 3rd party solution providers and maintain FAQ.
• Reporting various KPI’s (incidents, problems, changes, small projects) to management where applicable.
• Support of other applications and/or automated systems where necessary.
• Maintaining Pas-X MES relevant standard operating procedures.
• On call support may be required as time to support manufacturing.

Essential Qualifications

• Degree in IT, Engineering or a Science related discipline or relevant 3rd level qualification with appropriate experience.

Preferred Qualifications

• Pharmaceutical experience. Experience with MES systems is highly desirable.

Benefits Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours Integrity

Innovation

Impact

One Astellas

Accountability

Courage

Sense of Urgency

Outcome Focus

Skills And Capabilities Organizational Focus

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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