Validation Engineer (R&D)

For Process Development services in the Process Engineering area.

About fitspr

• We are a Service Provider company different 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 industry clients with top-notch quality talent.
• We're FITS!
• Are you the next piece?

Responsibilities

• Administrative, and according to business needs.
• 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.

Requirements

• The Technical Part: Bachelor Degree in Engineering and at least five (5) years of experience within the medical devices or pharmaceutical industry.

Preferred

• English and Spanish Soft Skills: Great attitude and strong desire to learn new skills.