Our company specializes in providing Integrated Engineering, Maintenance, Utilities and Specialized Technical Services for the Pharmaceutical, Parenteral, Chemical, & Medical Devices Manufacturing business sectors in compliance with Federal Government Regulations.
Qualifications and Skills
Degree in Engineering or Science of Engineering and 3 years of experience or more, within the pharmaceutical or medical device industry.
Exposure to engineering and manufacturing environment.
Knowledge in validation
Quality and Results Oriented
Fluency speaking and writing in English and Spanish
Responsibilities and Duties
Develops expertise knowledge of all factors that make a process to support the response to highly technical questions and situations, to solve quality issues, to improve process, or to confirm reliability of products.
Collaborates with technical experts, Design team, and other facilities for the process development of new devices. Supports equipment development efforts for new devices, and process improvements. These efforts may be the internal development of process equipment or coordination with an external equipment integration company.
Supports process owners. This support might include daily support of production operations as well as leading reliability and yield improvement activities for new products while handed off to the process owners.
Provides engineering support to the remote facilities, as required. Builds relationships with counterparts at the worldwide manufacturing facilities to support the virtual factory that has been established as well as Global Technology Teams.
Supports worldwide standardization of processes and products.
Incorporates Six Sigma and Lean Manufacturing tools to support the critical initiatives of improving quality, reducing scrap, increasing yield, meeting ship commitments, and driving down cycle-time through the development of new processes. Applies Lean Sigma methodology to new process development activities, and process enhancements. Full understanding of all process intricacies to provide engineering knowledge for troubleshooting and root cause analysis and corrective actions
Works on complex problems where analysis of situations or data requires an evaluation of many tangible and intangible factors. Individual will be required at times to make complex technical recommendations on product quality and reliability to sustain business activities.
Writes Process and Equipment Specifications when applicable.
Supports Product Return organization in providing root cause analysis with process expertise to explain field failures caused by new process issues.
Supports the coordination and guidance of integral analysis of the processes / technologies utilizing appropriate tools, acting supporting the technical expert. Complies with standardization of methods and processes with other sites.
Collaborates with Technical Experts to implement new Product/ Process activities across the facilities following Technology Roadmaps and Design Engineering activities.
Determines and puts in place Parameter Monitoring to understand the health and performance of the process.
Performs other position related duties as assigned.