Validation Engineer (R&D)

FITS LLC; Dorado (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

FITS LLC is seeking a Process Development Engineer to support equipment validation and tool qualification activities in the medical devices/pharmaceutical sector. You will design and review validation protocols, develop DOE plans, and generate technical documentation.

Fluency in English and Spanish is required, with an administrative shift as needed, and collaboration across Process Development and R&D. Responsibilities include designing tools in SolidWorks, supporting new processes, and

Qualifications

• Bachelor's degree in Engineering and at least five (5) years of experience in the medical devices or pharmaceutical industry.
• Bilingual: English and Spanish.
• Shift: Administrative, and according to business needs.

Responsabilités

• 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 gauges, 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.

Connaissances

Equipment validation

Validation protocols

Statistical sampling

DOE

Data analysis

Cross-functional collaboration

Formation

Bachelor's degree in Engineering

Outils

SolidWorks

Description du poste

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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent. We're FITS!

Are you the next piece?