{"schemaVersion":"jobsearcher.job.v1","id":"eb185a459fb5c73694c5857b","url":"https://jobsearcher.com/jobs/eb185a459fb5c73694c5857b","canonicalUrl":"https://jobsearcher.com/jobs/eb185a459fb5c73694c5857b","title":"Process Engineer","description":"Responsibilities: Seeking an experienced Process Engineer – Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing.\nWorking closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will ensure cartridge filling processes consistently meet production, quality, and regulatory objectives while supporting the successful startup of new manufacturing operations.\nDirect experience supporting cartridge filling lines is required. Candidates with experience limited to syringe filling will not be considered.\nRequirements: Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.\n5+ years of pharmaceutical manufacturing experience, preferably supporting sterile injectable operations.\nHands-on cartridge filling experience is required.\nStrong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles.\nExperience supporting equipment validation, process qualification, and manufacturing startup activities.\nExcellent troubleshooting, communication, and technical writing skills.\nMost Important Skills Needed: Direct cartridge filling line experience (Required)\nProcess Engineering within sterile pharmaceutical manufacturing\nAseptic filling operations\nEquipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)\nProcess optimization and manufacturing troubleshooting\nGMP manufacturing experience\nRoot cause investigations, CAPA, and deviation support\nCross-functional collaboration with Manufacturing, Validation, Automation, and Quality\nTechnical documentation, engineering studies, and protocol development\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Frederick","state":"MD","isRemote":false,"isActive":false,"createdAt":"2026-09-02T04:11:55.685Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-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","description":"Responsibilities: Seeking an experienced Process Engineer – Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing.\nWorking closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will ensure cartridge filling processes consistently meet production, quality, and regulatory objectives while supporting the successful startup of new manufacturing operations.\nDirect experience supporting cartridge filling lines is required. Candidates with experience limited to syringe filling will not be considered.\nRequirements: Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.\n5+ years of pharmaceutical manufacturing experience, preferably supporting sterile injectable operations.\nHands-on cartridge filling experience is required.\nStrong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles.\nExperience supporting equipment validation, process qualification, and manufacturing startup activities.\nExcellent troubleshooting, communication, and technical writing skills.\nMost Important Skills Needed: Direct cartridge filling line experience (Required)\nProcess Engineering within sterile pharmaceutical manufacturing\nAseptic filling operations\nEquipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)\nProcess optimization and manufacturing troubleshooting\nGMP manufacturing experience\nRoot cause investigations, CAPA, and deviation support\nCross-functional collaboration with Manufacturing, Validation, Automation, and Quality\nTechnical documentation, engineering studies, and protocol development\n\n#J-18808-Ljbffr","datePosted":"2026-09-02T04:11:55.685Z","dateModified":"2026-09-02T04:11:55.685Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Frederick","addressRegion":"MD","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"eb185a459fb5c73694c5857b"},"url":"https://jobsearcher.com/jobs/eb185a459fb5c73694c5857b"}}