Validation Engineer

ProQualityNetwork; Dorado (PR); On-site; USD 60,000 - 100,000; Full time

Job summary

ProQualityNetwork in North of Puerto Rico is seeking an experienced R&D Engineer and/or Validation Engineer to provide independent technical support through experimental execution, data analysis, and collaboration within project teams.

The role focuses on equipment validation (IQ) and tool qualification (TQF), applying SolidWorks for tool and fixture design, and contributing to process development and design of experiments across PD and R&D projects.

Qualifications

• Relevant scientific or engineering experience supporting technical projects, experimental execution, and data analysis.
• Knowledge of equipment validation, including IQ, and tool qualification activities (TQF).
• SolidWorks knowledge and the ability to work with tool and fixture designs.
• Experience or knowledge related to process development, statistical sampling plans, test methods, and experimental protocols.
• Ability to analyze data, prepare technical documentation, and communicate results effectively.
• Ability to work independently within the assigned functional area and collaborate with cross-functional teams.

Responsibilities

• Support equipment validation activities, including IQ and tool qualification activities (TQF).
• Review and develop equipment validation protocols and reports, and provide support to other functional areas throughout validation activities.
• Apply SolidWorks knowledge to design, update, and review tools and fixtures to meet test method requirements and product needs.
• Collaborate with Process Development teams to qualify new processes efficiently, supporting statistical sampling plans and other process development activities.
• Design and develop in-process and incoming quality systems for new processes and components.
• Prepare and maintain equipment documentation, including equipment entries, evaluations, PM procedures, and calibration procedures.

Skills

Equipment validation

IQ/TQF

SolidWorks

DOE design

Data analysis

Technical documentation

Independent work

Tools

Calibration procedures

Job description

Location: North of Puerto Rico (Only open to Puerto Rico Residents)

Contract Onsite opportunity

Position Summary

Our client is seeking an R&D Engineer and/or Validation Engineer with relevant scientific or engineering experience to provide independent technical support through experimental execution, data analysis, and collaboration within project teams. The successful candidate will apply scientific and engineering principles, expand technical knowledge across disciplines, and contribute to the development and qualification of processes, equipment, tools, and test methods.

Key Responsibilities

• Support equipment validation activities, including Installation Qualification (IQ), and tool qualification activities (TQF).
• Review and develop equipment validation protocols and reports, and provide support to other functional areas throughout validation activities.
• Apply SolidWorks knowledge to design, update, and review tools and fixtures to meet test method requirements and product needs.
• Collaborate with Process Development teams to qualify new processes efficiently, supporting statistical sampling plans and other process development activities.
• Design and develop in-process and incoming quality systems for new processes and components.
• Prepare and maintain equipment documentation, including equipment entries, evaluations, preventive maintenance (PM) procedures, and calibration procedures, as required.
• Identify and define the gauges, tools, and equipment required for newly developed test methods.
• Develop manufacturing instructions to support new test methods.
• Collaborate cross-functionally to support Process Development (PD) and Research and Development (R&D) objectives.
• Maintain current knowledge of relevant technologies and scientific literature, identifying potential applications for existing technologies, equipment, systems, and assays.
• Support research and testing of new technologies and research targets within the assigned functional area.
• Design and document experiments and protocols, including Design of Experiments (DOE), of limited complexity in alignment with project objectives, with guidance from senior technical staff as needed.
• Independently execute experiments within the assigned functional area and perform multiple experimental techniques and processes.
• Conduct complex data analysis, identify and recommend solutions to data-related issues, resolve basic problems independently, and compare results against historical data.
• Summarize experimental findings, prepare technical reports, complete experimental records and laboratory notebook documentation, and participate in peer reviews of experimental documentation as needed.
• Propose and develop methods and processes independently or with minimal direction from senior technical staff.
• Contribute to project teams primarily through experimental execution and, as appropriate, provide technical input on projects of limited complexity.
• Identify the resources required to achieve project milestones and recommend functional resource needs to the team leader.

Qualifications and Technical Requirements

• Relevant scientific or engineering experience supporting technical projects, experimental execution, and data analysis.
• Knowledge of equipment validation, including IQ, and tool qualification activities (TQF).
• SolidWorks knowledge and the ability to work with tool and fixture designs.
• Experience or knowledge related to process development, statistical sampling plans, test methods, and experimental protocols.
• Ability to analyze data, prepare technical documentation, and communicate results effectively.
• Ability to work independently within the assigned functional area and collaborate with cross-functional teams.
• Ability to manage assigned technical activities and contribute to project milestones.