R&D Validation Engineer

Validation-; Dorado (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Pinnaql is seeking an R&D Validation Engineer to support equipment validation (IQ), tool qualification (TQF), and process development across R&D, PD, and manufacturing. The engineer will design fixtures, develop validation protocols, and generate documentation to ensure compliant, scalable operations.

Candidate will work cross-functionally to qualify new processes, perform data analysis, and contribute to DOE studies.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Experience with equipment validation and tool qualification in regulated settings.
• SolidWorks proficiency for fixtures and gages design.
• Strong knowledge of IQ/OQ/PQ and validation documentation.

Responsibilities

• Support equipment validation (IQ) and tool qualification activities (TQF).
• Review and develop equipment validation protocols and reports.
• Design, update and review tools and fixtures using SolidWorks.
• Qualify new processes and assist on DOE and sampling plans.
• Generate validation documentation and calibration procedures as required.
• Collaborate cross-functionally with PD, R&D, Quality, and Operations.
• Summarize results and prepare technical reports.

Skills

Equipment validation

Tool qualification

Process development

DOE

Data analysis

Cross-functional collaboration

IQ/OQ/PQ understanding

Regulated documentation

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking an R&D Validation Engineer to support equipment validation (IQ), tool qualification (TQF), and process development activities across R&D, PD, and manufacturing functions. This role is responsible for developing and executing validation protocols, designing tools and fixtures, generating technical documentation, and supporting new technology evaluations. The engineer works cross-functionally to qualify new processes, ensure compliance with site procedures, and deliver high-quality technical outputs that enable reliable, scalable operations.

Description:

• 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.
• 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:

• Bachelor’s degree in Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related technical field.
• 2–5+ years of experience in equipment validation, tooling qualification, process development, or related regulated technical environment.
• Proficiency in SolidWorks for designing, updating, and reviewing fixtures, tools, and gages.
• Strong understanding of IQ/OQ/PQ, validation principles, and equipment documentation requirements.
• Experience designing or supporting test methods, sampling plans, and quality systems.
• Ability to perform complex data analysis, interpret results, and generate technical reports.
• Demonstrated ability to design and execute experiments, including DOE.
• Strong cross-functional communication skills and ability to work with PD, R&D, Quality, and Operations.
• Familiarity with PM, calibration, and equipment lifecycle documentation.
• Strong documentation skills and adherence to regulated record-keeping requirements.
• Knowledge of EH&S procedures and laboratory safety practices.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.