{"schemaVersion":"jobsearcher.job.v1","id":"ca1498a2ea6b44f55d963eca","url":"https://jobsearcher.com/jobs/ca1498a2ea6b44f55d963eca","canonicalUrl":"https://jobsearcher.com/jobs/ca1498a2ea6b44f55d963eca","title":"Senior Process Engineer","description":"Position Summary\n\nThe Senior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.\n\nDuties and Responsibilities\n\nAnalyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product\nEvaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis\nPropose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale\nPropose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product\nTake an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing\nIdentify and order materials required to perform development and manufacturing\nIdentify tooling and equipment required to perform development and manufacturing\nCreate documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards\nDue diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality\nPropose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product\nCompile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions\nAnalyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product\nMaintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed\nStudy effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product\nDevelop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product\nWrite technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests\nCarry out all job responsibilities in a safe manner\nDevelop equipment and processes that meet safety codes, policies and guidelines\nProvide for the safety and well-being of operators, maintenance, and other personnel\nConfer with scientists or engineers to conduct analyses of research projects, interpret test results or develop procedure and standard tests\nOther duties as assigned\n\nRegulatory Responsibilities\n\nConduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable\nProvide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines\n\nSupervisory Responsibilities\n\nLead/support validation activities including equipment validation and process validation\nLead problem solving and investigate quality events related to formulation process or batch records\nPropose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards\nLead or participate in root cause analysis and quality event investigation such as OOS and deviations\nSupervise, mentor and develop team members or relevant personnel across departments\n\nExperience\n\nA minimum of three (3) years of experience in pharmaceutical research and manufacturing\n\nEducation\n\nBachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science\n\nKnowledge, Skills & Abilities\n\nExperience in sterile manufacturing is preferred\nExperience in lyophilization and terminal sterilization techniques are a plus\nKnowledge of parenteral drug product manufacturing\nProficient with calculation, data analysis, statistics and applied mathematics\nExceptional computer skills including Microsoft Office, Visio or other related software\nExcellent writing skills\nAttention to detail\n\nPhysical Requirements\n\nAbility to sit for prolonged periods of time\nAbility to stand for prolonged periods of time\nAble to lift up to 50lbs","company":"Sharp Sterile Manufacturing","rawCompany":"sharp sterile manufacturing","city":"Lee","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:36:37.601Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-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":"Senior Process Engineer","description":"Position Summary\n\nThe Senior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.\n\nDuties and Responsibilities\n\nAnalyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product\nEvaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis\nPropose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale\nPropose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product\nTake an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing\nIdentify and order materials required to perform development and manufacturing\nIdentify tooling and equipment required to perform development and manufacturing\nCreate documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards\nDue diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality\nPropose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product\nCompile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions\nAnalyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product\nMaintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed\nStudy effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product\nDevelop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product\nWrite technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests\nCarry out all job responsibilities in a safe manner\nDevelop equipment and processes that meet safety codes, policies and guidelines\nProvide for the safety and well-being of operators, maintenance, and other personnel\nConfer with scientists or engineers to conduct analyses of research projects, interpret test results or develop procedure and standard tests\nOther duties as assigned\n\nRegulatory Responsibilities\n\nConduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable\nProvide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines\n\nSupervisory Responsibilities\n\nLead/support validation activities including equipment validation and process validation\nLead problem solving and investigate quality events related to formulation process or batch records\nPropose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards\nLead or participate in root cause analysis and quality event investigation such as OOS and deviations\nSupervise, mentor and develop team members or relevant personnel across departments\n\nExperience\n\nA minimum of three (3) years of experience in pharmaceutical research and manufacturing\n\nEducation\n\nBachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science\n\nKnowledge, Skills & Abilities\n\nExperience in sterile manufacturing is preferred\nExperience in lyophilization and terminal sterilization techniques are a plus\nKnowledge of parenteral drug product manufacturing\nProficient with calculation, data analysis, statistics and applied mathematics\nExceptional computer skills including Microsoft Office, Visio or other related software\nExcellent writing skills\nAttention to detail\n\nPhysical Requirements\n\nAbility to sit for prolonged periods of time\nAbility to stand for prolonged periods of time\nAble to lift up to 50lbs","datePosted":"2026-04-14T10:36:37.601Z","dateModified":"2026-04-14T10:36:37.601Z","hiringOrganization":{"@type":"Organization","name":"Sharp Sterile Manufacturing","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Lee","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ca1498a2ea6b44f55d963eca"},"url":"https://jobsearcher.com/jobs/ca1498a2ea6b44f55d963eca"}}