PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

PharmEng Technology is seeking an experienced MES Application Engineer for a project in Houston Texas to help drive our solution-based business model and take our designs to the next level. The MES Application Engineer is responsible for supporting activities such as requirements gathering, definition, and application/test/implementation of Manufacturing Execution System (MES) client projects; primarily, but not limited to, the pharmaceutical/biotech industries.

Job Responsibilities:

• Responsible for execution of protocols for testing and validating electronic batch records.
• Responsible for testing of MES systems.
• Working with MES leads, system users and process owners to develop, revise and maintain MES recipes.
• Responsible for creating and maintaining electronic logbooks and electronic batch records via tickets using ServiceNow.
• Responsible for creating and maintaining electronic batch records and configured production recipes using object libraries.
• Responsible for fulfilling all process change controls, Corrective and Preventative Action, deviations and create new workflows based on client needs.
• Responsible for gathering and documenting customer requirements for MES system through client interviews, documentation analysis and Workflow Process Mapping.
• Responsible for assisting in designing and deployment of MES systems to replace paper based or manual systems including batch records, weigh & dispense, warehouse management and material tracking in a pharmaceutical or medical device environment.
• Actively participate in fit-gap analysis of customer requirements vs. MES system functionality.
• Provide technical input to help troubleshoot issues during MES usage and support end-users in MES navigation, EBR execution and general system utilization to ensure users become self-sufficient.
• Familiarity with FDA regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e., GMP and GLP).
• Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments.