R/ D Engineer - North Puerto Rico Region

Posted 10 Days Ago
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Dorado, PRI
In-Office
Entry level
Food • Professional Services • Business Intelligence • Pharmaceutical
The Role
Provides independent technical support for R&D and process development experiments. Responsibilities include equipment validation, tool qualification, protocol and report development, SolidWorks-based fixture design, statistical sampling, quality system development, test method documentation, data analysis, technical reporting, and cross-functional collaboration. The role also supports new technology research, experimental execution, equipment documentation, inventory activities, and compliance with EH&S and site procedures.
Summary Generated by Built In

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.


·       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’ needs.

·       Work with 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.


 

 

 

 

·       Learn to identify the supplies required to complete work and orders supplies; may submit sample requests via the SOP.

·       Adheres to all EH&S procedures and general housekeeping SOPs.

·       Compliance with site and department specific procedures on record keeping, use of logbooks, materials receiving, and inventory control.

·       Completes time records and reports projects allocated time.

·       May identify areas of lab/infrastructure improvement (SOP correctness, business practices) and may participate in executing solutions.



Requirements
5+ years of experience is preferred. Candidates with engineering background are required. Electrical and mechanical engineers are preferred.

Skills Required

  • Scientific or engineering experience supporting experiment execution and analysis
  • SolidWorks knowledge and ability to design, update, and review tools and fixtures
  • Ability to support equipment validation and tool qualification activities
  • Ability to perform complex data analysis and develop technical reports
  • Ability to work cross-functionally on process development and R&D projects
  • Ability to follow EH&S, documentation, recordkeeping, and inventory-control procedures
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The Company
11 Employees

What We Do

ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.

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