{"schemaVersion":"jobsearcher.job.v1","id":"5a518784184fce1fe3f062d4","url":"https://jobsearcher.com/jobs/5a518784184fce1fe3f062d4","canonicalUrl":"https://jobsearcher.com/jobs/5a518784184fce1fe3f062d4","title":"R&D Validation Engineer","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.\n\nWe 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.\n\nDescription:\n\nSupport equipment validation (IQ) and tool qualification activities (TQF)\nResponsible for reviewing and developing equipment validation protocols and reports. Support other functional areas during the validation activities.\nHas SolidWorks knowledge and be capable of designing, updating and reviewing tools and fixtures to satisfy test methods and products necessities.\nWork with the Process Development and team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.\nDesign and develop in-process and receiving quality systems for new processes and components.\nGenerate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required.\nDefine gages, tools and equipment for the test methods developed.\nGenerate manufacturing instructions for new test methods being developed.\nWork cross-functionally with other departments to accomplish PD and R&D tasks.\nRemains knowledgeable of technologies (including relevant literature) within functional area and may identify new applications for existing technologies (e.g. assays, equipment, systems, etc.).\nSupports, research, and tests new technologies and targets for research within functional area.\nMay 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.\nCompletes complex data analysis; identifies and proposes solutions to problematic data; solves basic issues independently at an appropriate level; compares results with historical data.\nSummarizes results, generates technical reports, completes experimental paperwork/lab notebook documentation, and may peer review experimental documentation.\nProposes and develops methods and processes independently or under minimal direction from senior technical staff.\nParticipates as an extended team member primarily for experimental execution and secondarily as a scientific consultant for projects of limited complexity.\nPerforms multiple experimental techniques and processes according to functional area.\nIdentifies what resources are required to meet project milestones; makes recommendations to team leader for project resource needs within function\n\nQualifications:\n\nBachelor’s degree in Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related technical field.\n2–5+ years of experience in equipment validation, tooling qualification, process development, or related regulated technical environment.\nProficiency in SolidWorks for designing, updating, and reviewing fixtures, tools, and gages.\nStrong understanding of IQ/OQ/PQ, validation principles, and equipment documentation requirements.\nExperience designing or supporting test methods, sampling plans, and quality systems.\nAbility to perform complex data analysis, interpret results, and generate technical reports.\nDemonstrated ability to design and execute experiments, including DOE.\nStrong cross-functional communication skills and ability to work with PD, R&D, Quality, and Operations.\nFamiliarity with PM, calibration, and equipment lifecycle documentation.\nStrong documentation skills and adherence to regulated record-keeping requirements.\nKnowledge of EH&S procedures and laboratory safety practices.\n\nAt 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.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nPinnaql 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.","company":"Validation","rawCompany":"validation","city":"Dorado","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-10-31T09:21:04.558Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"R&D Validation Engineer","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.\n\nWe 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.\n\nDescription:\n\nSupport equipment validation (IQ) and tool qualification activities (TQF)\nResponsible for reviewing and developing equipment validation protocols and reports. Support other functional areas during the validation activities.\nHas SolidWorks knowledge and be capable of designing, updating and reviewing tools and fixtures to satisfy test methods and products necessities.\nWork with the Process Development and team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.\nDesign and develop in-process and receiving quality systems for new processes and components.\nGenerate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required.\nDefine gages, tools and equipment for the test methods developed.\nGenerate manufacturing instructions for new test methods being developed.\nWork cross-functionally with other departments to accomplish PD and R&D tasks.\nRemains knowledgeable of technologies (including relevant literature) within functional area and may identify new applications for existing technologies (e.g. assays, equipment, systems, etc.).\nSupports, research, and tests new technologies and targets for research within functional area.\nMay 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.\nCompletes complex data analysis; identifies and proposes solutions to problematic data; solves basic issues independently at an appropriate level; compares results with historical data.\nSummarizes results, generates technical reports, completes experimental paperwork/lab notebook documentation, and may peer review experimental documentation.\nProposes and develops methods and processes independently or under minimal direction from senior technical staff.\nParticipates as an extended team member primarily for experimental execution and secondarily as a scientific consultant for projects of limited complexity.\nPerforms multiple experimental techniques and processes according to functional area.\nIdentifies what resources are required to meet project milestones; makes recommendations to team leader for project resource needs within function\n\nQualifications:\n\nBachelor’s degree in Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related technical field.\n2–5+ years of experience in equipment validation, tooling qualification, process development, or related regulated technical environment.\nProficiency in SolidWorks for designing, updating, and reviewing fixtures, tools, and gages.\nStrong understanding of IQ/OQ/PQ, validation principles, and equipment documentation requirements.\nExperience designing or supporting test methods, sampling plans, and quality systems.\nAbility to perform complex data analysis, interpret results, and generate technical reports.\nDemonstrated ability to design and execute experiments, including DOE.\nStrong cross-functional communication skills and ability to work with PD, R&D, Quality, and Operations.\nFamiliarity with PM, calibration, and equipment lifecycle documentation.\nStrong documentation skills and adherence to regulated record-keeping requirements.\nKnowledge of EH&S procedures and laboratory safety practices.\n\nAt 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.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nPinnaql 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.","datePosted":"2026-10-31T09:21:04.558Z","dateModified":"2026-10-31T09:21:04.558Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dorado","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5a518784184fce1fe3f062d4"},"url":"https://jobsearcher.com/jobs/5a518784184fce1fe3f062d4"}}