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.