Engineer II - Process and Product
Baxter View all jobs
- Puerto Rico
- Permanent
- Full-time
- Responsible for providing Engineering support to the manufacturing areas. Work with procedures, FMEAs, protocols (IQ/OQ/PQ, TMV, Studies, etc.), customer complaints, investigations, CAPA actions, Change Controls and improvement projects. Interact with Local and Divisional function groups.
- Participate in multifunctional projects to contribute with plan manufacturing strategies.
- Provide technical support to Manufacturing, Engineering and Quality areas.
- Improve manufacturing processes using analytical tools and Design of Experiments as required.
- Participate in the evaluation of customer complaints, NCR Investigations and provide suggestions for process/product improvements and non-conformance investigations.
- Provide technical support in the implementation of Value Improvement Projects, using Problem Solving Tools as DMAIC, 8-Steps, etc.
- Support and assists in the implementation of new product introductions, existing product design modifications, manufacturing improvements giving direct support on change process as change control owner and/or action owner on local or divisional projects.
- Perform and maintain process or product validations, re-validation and Validation Maintenance programs using Local or Divisional engineering resources.
- Generate validation protocols and reports for the qualification of process equipment's or process changes.
- Develop and update standard operating procedures for new and existing processes and equipment.
- Provide technical training support to manufacturing personnel.
- Coordinate and perform Local and Divisional engineering project activities under minimal supervision.
- Interact under minimal supervision with various Local and Divisional function groups.
- Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
- Observe, maintain confidentiality and data privacy rules at all times.
- May require occasional travel.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Knowledge of the basic principles in various engineering disciplines. Must have initial training in concepts of "Six Sigma" quality techniques. Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician. Uses computer applications to do process analysis. Knowledge of problem solving and statistical techniques. Good interpersonal skills. Knowledge of GMP, FDA and OSHA. Some travelling is required. Team and results oriented. Have regular communication with supervisors and peers. Maintain external interface channels with offshore facilities.
- Include the education and/or experience that is necessary to perform the job satisfactorily.
- Bachelor’s degree in Mechanical, Industrial, Electrical or Chemical Engineering. 2-3 years of experience in Engineering.
- Bilingual (Spanish and English) Oral and Writing.
- Light Work: Exerting up to 20 pounds of force occasionally and/or a 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Physical demands requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible.