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.
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.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.