For Process Development services in the Process Engineering area.
WHAT MAKES YOU A FIT: The Technical Part:- Bachelor Degree in Engineering and at least five (5) years of experience within the medical devices or pharmaceutical industry.
- Bilingual: English and Spanish
- Soft Skills: Great attitude and strong desire to learn new skills.
- Shift: Administrative, and according to business needs.
- Experience in:
- Equipment validation and qualification activities, including Installation Qualification (IQ) and Tool Qualification (TQF)
- Development and review of validation protocols and reports.
- Statistical sampling plans, experimental design, and data analysis.
- Design of Experiments (DOE) and execution of experimental protocols.
- Technical reports, manufacturing instructions, and experimental documentation.
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)- Support equipment validation (IQ) and tool qualification (TQF) activities.
- Develop and review equipment validation protocols and reports, while supporting other functional areas throughout validation activities.
- Design, update, and review tools and fixtures using SolidWorks to meet product and test method requirements.
- Collaborate with Process Development to qualify new processes, including support for statistical sampling plans and development activities.
- Design and develop in-process and receiving quality systems for new processes and components.
- Generate equipment documentation, including equipment entries, evaluations, PM, and calibration procedures.
- Define the gages, tools, and equipment required for newly developed test methods and generate associated manufacturing instructions.
- Design, document, and execute experimental protocols, including DOE, and perform data analysis to identify issues and recommend solutions.
- Summarize experimental results and generate technical reports and supporting documentation.
- Work cross-functionally with Process Development, R&D, and other departments to accomplish project objectives and support the evaluation of new technologies.
