Validation Engineer (R&D)

Flexible & Integrated Technical Services, LLC•Dorado, PR

About The Position

The Validation Engineer supports Process Development services in the Process Engineering area. The role performs equipment validation and tool qualification, develops and reviews validation documentation, and collaborates with Process Development, R&D, and other departments to qualify processes and evaluate new technologies. It also involves designing and documenting tools, fixtures, test methods, and quality systems, as well as conducting experiments and analyzing data.

Requirements

Bachelor’s degree in Engineering.
At least five years of experience within the medical device or pharmaceutical industry.
Bilingual in English and Spanish.
Experience with equipment validation and qualification activities, including Installation Qualification (IQ) and Tool Qualification (TQF).
Experience developing and reviewing validation protocols and reports.
Experience with statistical sampling plans, experimental design, and data analysis.
Experience with Design of Experiments (DOE) and executing experimental protocols.
Experience preparing technical reports, manufacturing instructions, and experimental documentation.
Great attitude and a strong desire to learn new skills.

Responsibilities

Support equipment validation (IQ) and tool qualification (TQF) activities.
Develop and review equipment validation protocols and reports, and support 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 supporting 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, preventive maintenance (PM), and calibration procedures.
Define gages, tools, and equipment required for newly developed test methods and generate associated manufacturing instructions.
Design, document, and execute experimental protocols, including DOE, and analyze data 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 evaluation of new technologies.