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MES Validation Engineer - Ireland
Posted on : 27 April 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- Reporting to the to MES Process Steward, the MES Engineer will design, configure and test MBRs in an MES systems to support manufacturing activities in a regulated environment.
- The ideal candidate will work closely with business management and users to define the needs and design solutions that add value to the company.
- Ensure that the MBR design testing and release is in line with all site procedures and standards
- Execute the appropriate change control documentation to assure the MES system is in a state of control and compliance and that any changes to MBRs does not have an impact on the validated state of the system.
- Development and execution of the qualification of MBRs/Master Data documentation
- Development of life cycle documents necessary to address the validation lifecycle
- Preparation / testing of validation protocols, and all associated documentation for equipment and systems
- Review and approval of all Computer Systems / Software Validation Documentation
- Required to comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture.
- May be required to perform other duties as assigned.
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Relevant 3 years plus experience and a particular skill set in MES or Information Technology; ideally in supporting a pharmaceutical manufacturing, GMP setting
Extensive technical and operational expertise in one of more of the following disciplines:
- Computer Systems Validation
- MES Systems
- Business Systems
- Manufacturing Execution Systems
- Instrumentation/Automation & Control
- BMS / SCADA / DCS Systems
- Control System/Shop floor Integration
- Financial Systems / Inventory Management Systems / SAP
- Proficiency in Microsoft Office and job related computer applications required
- Report, standards, policy writing skills required
- Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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