R&D / Validation Engineer

Inteldot; Dorado (PR); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Inteldot is seeking an Engineer with hands-on science/engineering experience to provide independent technical support through experiment execution and analysis as part of a project team in Puerto Rico.

You will build knowledge across disciplines, develop validation protocols, review reports, and design tools and fixtures in SolidWorks to meet test methods and product needs. The role involves cross-functional collaboration with Process Development and R&D and may include DOE-style experimentation.

Competenze

• Education and experience: BA/BS in Engineering or related field with at least 3 years in equipment validation, process development, or R&D.
• Experience reviewing IQ/TQF protocols and validation reports.
• Proficient in SolidWorks for designing and reviewing tools and fixtures.

Mansioni

• Support equipment validation (IQ) and tool qualification activities (TQF).
• Review and develop equipment validation protocols and reports.
• Design and update tools/fixtures using SolidWorks.
• Collaborate with Process Development and R&D to qualify new processes.
• Create equipment documentation and manufacturing instructions.
• Define gauges, tools, and test methods; generate test method documentation.

Conoscenze

Experiment execution

Data analysis

Technical reporting

Formazione

Bachelor’s degree in Engineering or related field

Strumenti

SolidWorks

Descrizione del lavoro

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.

Administrative shift

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.