{"schemaVersion":"jobsearcher.job.v1","id":"33d09c641c0a99bad8341838","url":"https://jobsearcher.com/jobs/33d09c641c0a99bad8341838","canonicalUrl":"https://jobsearcher.com/jobs/33d09c641c0a99bad8341838","title":"Process Development Sr. Scientist","description":"We are seeking a Process Development Sr. Scientist to support process development, process validation, technical documentation, and manufacturing support activities within a highly regulated manufacturing environment. This position offers the opportunity to work in a cross-functional setting, contributing to process improvements, validation initiatives, and commercial manufacturing readiness while ensuring compliance with quality and regulatory requirements.\nResponsibilities\nSupport process development, process characterization, and process validation activities.\nAuthor, review, and execute validation protocols, technical documentation, and validation reports.\nSupport equipment qualification and validation activities in compliance with GMP requirements.\nAnalyze process performance data, identify trends, and recommend process improvements using scientific and risk-based approaches.\nCollaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to support manufacturing readiness and process optimization.\nParticipate in investigations, root cause analysis, CAPA activities, and implementation of corrective actions.\nSupport change control activities and technical documentation updates.\nContribute to continuous improvement initiatives that enhance process robustness, compliance, and operational efficiency.\nSupport manufacturing operations during validation, characterization, and other critical production activities, including flexibility to work alternate shifts or weekends when required.\nQualifications\nDoctorate (PhD, PharmD, or MD); OR Master's degree with 3+ years of relevant scientific experience; OR Bachelor's degree with 5+ years of relevant scientific experience.\nDegree in Engineering, Microbiology, or another related scientific discipline.\nExperience supporting validation activities in a highly regulated manufacturing environment.\nExperience developing and/or executing validation protocols and technical documentation.\nKnowledge of GMP requirements and quality systems.\nStrong analytical, technical writing, and problem-solving skills.\nAbility to work independently while collaborating effectively with cross-functional teams.\nWillingness to work different shifts and weekends during characterization or validation activities.\nExperience supporting pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.\nExperience with process monitoring, process characterization, and continuous improvement initiatives.\nKnowledge of statistical tools such as Minitab or similar software.\nExperience with risk management methodologies and data analysis.\nStrong communication, organizational, and project management skills.\nIf you are passionate about process development, validation, and scientific problem-solving in a regulated manufacturing environment, we encourage you to apply.\nJob Type: Full-time\nPay: $55.00 - $60.00 per hour\nEducation:\nBachelor's (Preferred)\nExperience:\nsupporting validation activities: 5 years (Preferred)\ndeveloping and/or executing validation protocols: 5 years (Preferred)\nGMP requirements and quality systems: 5 years (Preferred)\ncharacterization: 5 years (Preferred)\nsupporting pharmaceutical, biotechnology, medical device: 5 years (Preferred)\nprocess monitoring: 5 years (Preferred)\nstatistical tools such as Minitab or similar software: 5 years (Preferred)\nrisk management methodologies: 5 years (Preferred)\ndata analysis: 5 years (Preferred)\nWork Location: In person","company":"Prpdg","rawCompany":"prpdg","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-08-03T21:28:56.052Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-1012.00","title":"Food Scientists and Technologists","slug":"food-scientists-and-technologists"},{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"}],"industries":[{"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"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Sr. Scientist","description":"We are seeking a Process Development Sr. Scientist to support process development, process validation, technical documentation, and manufacturing support activities within a highly regulated manufacturing environment. This position offers the opportunity to work in a cross-functional setting, contributing to process improvements, validation initiatives, and commercial manufacturing readiness while ensuring compliance with quality and regulatory requirements.\nResponsibilities\nSupport process development, process characterization, and process validation activities.\nAuthor, review, and execute validation protocols, technical documentation, and validation reports.\nSupport equipment qualification and validation activities in compliance with GMP requirements.\nAnalyze process performance data, identify trends, and recommend process improvements using scientific and risk-based approaches.\nCollaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to support manufacturing readiness and process optimization.\nParticipate in investigations, root cause analysis, CAPA activities, and implementation of corrective actions.\nSupport change control activities and technical documentation updates.\nContribute to continuous improvement initiatives that enhance process robustness, compliance, and operational efficiency.\nSupport manufacturing operations during validation, characterization, and other critical production activities, including flexibility to work alternate shifts or weekends when required.\nQualifications\nDoctorate (PhD, PharmD, or MD); OR Master's degree with 3+ years of relevant scientific experience; OR Bachelor's degree with 5+ years of relevant scientific experience.\nDegree in Engineering, Microbiology, or another related scientific discipline.\nExperience supporting validation activities in a highly regulated manufacturing environment.\nExperience developing and/or executing validation protocols and technical documentation.\nKnowledge of GMP requirements and quality systems.\nStrong analytical, technical writing, and problem-solving skills.\nAbility to work independently while collaborating effectively with cross-functional teams.\nWillingness to work different shifts and weekends during characterization or validation activities.\nExperience supporting pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.\nExperience with process monitoring, process characterization, and continuous improvement initiatives.\nKnowledge of statistical tools such as Minitab or similar software.\nExperience with risk management methodologies and data analysis.\nStrong communication, organizational, and project management skills.\nIf you are passionate about process development, validation, and scientific problem-solving in a regulated manufacturing environment, we encourage you to apply.\nJob Type: Full-time\nPay: $55.00 - $60.00 per hour\nEducation:\nBachelor's (Preferred)\nExperience:\nsupporting validation activities: 5 years (Preferred)\ndeveloping and/or executing validation protocols: 5 years (Preferred)\nGMP requirements and quality systems: 5 years (Preferred)\ncharacterization: 5 years (Preferred)\nsupporting pharmaceutical, biotechnology, medical device: 5 years (Preferred)\nprocess monitoring: 5 years (Preferred)\nstatistical tools such as Minitab or similar software: 5 years (Preferred)\nrisk management methodologies: 5 years (Preferred)\ndata analysis: 5 years (Preferred)\nWork Location: In person","datePosted":"2026-08-03T21:28:56.052Z","dateModified":"2026-08-03T21:28:56.052Z","hiringOrganization":{"@type":"Organization","name":"Prpdg","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"33d09c641c0a99bad8341838"},"url":"https://jobsearcher.com/jobs/33d09c641c0a99bad8341838"}}