R&D / Validation Engineer

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Position Summary

We are seeking an Engineer with appropriate scientific/engineering experience to provide independent technical support through experiment execution and analysis as part of a project team. Builds scientific knowledge and concepts within and across disciplines surrounding core business principles.

Key Responsibilities

• Support equipment validation (IQ) and tool qualification activities (TQF)
• Responsible for reviewing and developing equipment validation protocols and reports. Support other functional areas during the validation activities.
• Has SolidWorks knowledge and be capable of designing, updating and reviewing tools and fixtures to satisfy test methods and products necessities.
• Work with the Process Development and team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.
• Design and develop in-process and receiving quality systems for new processes and components.
• Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required.
• Define gages, tools and equipment for the test methods developed.
• Generate manufacturing instructions for new test methods being developed.
• Work cross-functionally with other departments to accomplish PD and R&D tasks.
• Remains knowledgeable of technologies (including relevant literature) within functional area and may identify new applications for existing technologies (e.g. assays, equipment, systems, etc.).
• Supports, research, and tests new technologies and targets for research within functional area.
• May design/document experiments/protocols (e.g. DOE) of limited complexity to align with project goals with support from senior technical staff; executes independently within functional area.
• Completes complex data analysis; identifies and proposes solutions to problematic data; solves basic issues independently at an appropriate level; compares results with historical data.
• Summarizes results, generates technical reports, completes experimental paperwork/lab notebook documentation, and may peer review experimental documentation.
• Proposes and develops methods and processes independently or under minimal direction from senior technical staff.
• Participates as an extended team member primarily for experimental execution and secondarily as a scientific consultant for projects of limited complexity.
• Performs multiple experimental techniques and processes according to functional area.
• Identifies what resources are required to meet project milestones; makes recommendations to team leader for project resource needs within function.

Qualifications Required

• Education & Experience: Bachelor’s degree in Engineering or a related scientific field, with minimun three (3) years of experience in equipment validation, process development, or R&D.
• Equipment Validation & Documentation: Experience developing and reviewing IQ protocols, equipment qualification documentation, validation reports, and maintenance/calibration procedures.
• CAD & Equipment Design: Proficiency in SolidWorks for designing, updating, and reviewing tools, fixtures, and equipment.
• Process Development & Quality Systems: Knowledge of process qualification, statistical sampling plans, quality systems, manufacturing instructions, and experimental methodologies such as DOE.
• Data Analysis & Technical Reporting: Ability to analyze experimental data, troubleshoot results, prepare technical reports, and collaborate cross-functionally with engineering, Process Development, and R&D teams.