{"schemaVersion":"jobsearcher.job.v1","id":"73ea7f5de21f3ccc0430bd06","url":"https://jobsearcher.com/jobs/73ea7f5de21f3ccc0430bd06","canonicalUrl":"https://jobsearcher.com/jobs/73ea7f5de21f3ccc0430bd06","title":"Process Engineer - Oral Solid Dosage (Granulation, Compression, Coating)","description":"About Company\nStark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.\n\nAbout Company\nStark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.\n\nProcess Engineer - Oral Solid Dosage (Granulation, Compression, Coating)\nJob Summary\nOur client, a mid-size pharmaceutical CDMO, is seeking an experienced Process Engineer to support Oral Solid Dosage manufacturing operations in a cGMP environment, with a strong emphasis on technology transfer. This role leads and supports the transfer of products and processes from development, pilot or external manufacturing sites into commercial manufacturing, ensuring process knowledge is transferred effectively and manufacturing readiness is achieved.\n\nThis is a hands-on OSD role. Candidates whose experience is in medical device, software validation, or non-pharmaceutical manufacturing will not be a fit.\n\nResponsibilities\n\nCoordinate cross-functional technology transfer activities from development, pilot or external sites into commercial manufacturing\n\nSupport scale-up efforts and drive execution of engineering, validation and manufacturing readiness activities\n\nPerform process optimization and troubleshoot manufacturing issues on OSD unit operations\n\nEvaluate process performance data and author technical protocols and reports\n\nSupport process characterization and Process Performance Qualification (PPQ) activities\n\nManage change controls and lead deviation investigations and CAPAs\n\nPartner with Manufacturing, Quality Assurance, Engineering, MS&T and Regulatory teams\n\nQualifications\n\nBachelor's degree in Chemical Engineering, Pharmaceutical Sciences or related discipline\n\nHands-on experience with OSD unit operations: blending, granulation, milling, compression, encapsulation, coating and packaging\n\nDemonstrated technology transfer experience into commercial manufacturing\n\nExperience supporting PPQ and process characterization\n\nWorking knowledge of cGMP requirements and commercial manufacturing operations\n\nExperience with change control, deviation investigation and CAPA\n\nStrong technical writing and problem-solving skills\n\nMust be legally authorized to work in the United States\n\nW2 employment only\n\n#J-18808-Ljbffr","company":"Stark Pharma Solutions","rawCompany":"stark pharma solutions","city":"Akron","state":"OH","isRemote":false,"isActive":true,"createdAt":"2026-09-15T04:38:15.464Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer - Oral Solid Dosage (Granulation, Compression, Coating)","description":"About Company\nStark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.\n\nAbout Company\nStark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.\n\nProcess Engineer - Oral Solid Dosage (Granulation, Compression, Coating)\nJob Summary\nOur client, a mid-size pharmaceutical CDMO, is seeking an experienced Process Engineer to support Oral Solid Dosage manufacturing operations in a cGMP environment, with a strong emphasis on technology transfer. This role leads and supports the transfer of products and processes from development, pilot or external manufacturing sites into commercial manufacturing, ensuring process knowledge is transferred effectively and manufacturing readiness is achieved.\n\nThis is a hands-on OSD role. Candidates whose experience is in medical device, software validation, or non-pharmaceutical manufacturing will not be a fit.\n\nResponsibilities\n\nCoordinate cross-functional technology transfer activities from development, pilot or external sites into commercial manufacturing\n\nSupport scale-up efforts and drive execution of engineering, validation and manufacturing readiness activities\n\nPerform process optimization and troubleshoot manufacturing issues on OSD unit operations\n\nEvaluate process performance data and author technical protocols and reports\n\nSupport process characterization and Process Performance Qualification (PPQ) activities\n\nManage change controls and lead deviation investigations and CAPAs\n\nPartner with Manufacturing, Quality Assurance, Engineering, MS&T and Regulatory teams\n\nQualifications\n\nBachelor's degree in Chemical Engineering, Pharmaceutical Sciences or related discipline\n\nHands-on experience with OSD unit operations: blending, granulation, milling, compression, encapsulation, coating and packaging\n\nDemonstrated technology transfer experience into commercial manufacturing\n\nExperience supporting PPQ and process characterization\n\nWorking knowledge of cGMP requirements and commercial manufacturing operations\n\nExperience with change control, deviation investigation and CAPA\n\nStrong technical writing and problem-solving skills\n\nMust be legally authorized to work in the United States\n\nW2 employment only\n\n#J-18808-Ljbffr","datePosted":"2026-09-15T04:38:15.464Z","dateModified":"2026-09-15T04:38:15.464Z","hiringOrganization":{"@type":"Organization","name":"Stark Pharma Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Akron","addressRegion":"OH","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"73ea7f5de21f3ccc0430bd06"},"url":"https://jobsearcher.com/jobs/73ea7f5de21f3ccc0430bd06"}}