{"schemaVersion":"jobsearcher.job.v1","id":"19eb8dfca78da88220f3ab3f","url":"https://jobsearcher.com/jobs/19eb8dfca78da88220f3ab3f","canonicalUrl":"https://jobsearcher.com/jobs/19eb8dfca78da88220f3ab3f","title":"Senior API Process Engineer Small Molecules","description":"Description\nDiscover your exciting role The Lead Process Engineer will serve as the technical authority for process design and execution on EPC projects involving Active Pharmaceutical Ingredient (API) facilities, with a focus on small molecule drug substances. This role will lead process engineering activities across all project phases—conceptual design, FEED, detailed engineering, and construction insuring compliance with client specifications, regulatory standards, and project objectives.\nExplore your tasks and responsibilities Process Design Leadership: Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), material and energy balances, and equipment specifications for API small molecule facilities.\nProject Execution : Lead process engineering deliverables for EPC projects, including design basis documents, process narratives, and datasheets.\nRegulatory & cGMP Compliance: Ensure designs meet pharmaceutical regulatory requirements, including cGMP, FDA, EMA, and ICH guidelines.\nClient Interface: Act as the primary process engineering contact for clients, providing technical guidance and ensuring alignment with project goals.\nRisk & Safety Analysis: Conduct HAZOP, risk assessments, and ensure compliance with EHS standards.\nConstruction & Commissioning Support: Provide field engineering support during installation, commissioning, and start-up phases.\nTeam Leadership: Mentor junior engineers and coordinate with multi-disciplinary teams (mechanical, electrical, automation) to deliver integrated solutions.\nOther duties as assigned\nShow your expertise Minimum Requirements:\n\nEducation: Bachelor’s or Master’s degree in Chemical Engineering.\nExperience:\n• 10+ years in process engineering, with at least 5 years in EPC project execution for pharmaceutical or chemical facilities.\n• Strong background in API small molecule processes and facility design.\n• Professional Engineer (PE) License\n• Nation Council of Examiners for Engineering and Surveying (NCEES) Record\nTechnical Skills:\n• Proficiency in process simulation tools (Aspen Plus, HYSYS) and engineering standards.\n• Knowledge of cGMP, regulatory compliance, and cleanroom design principles.\nSoft Skills:\n• Strong leadership, communication, and client-facing skills.\n• Ability to manage multiple priorities in a fast-paced EPC environment.\nPreferred\n• Professional Engineer (PE) License preferred\n• Nation Council of Examiners for Engineering and Surveying (NCEES) Record preferred\n• Experience with modular construction and advanced manufacturing technologies\n• Familiarity with ISPE guidelines and QbD principles\n• Prior involvement in large-scale greenfield or brownfield pharmaceutical projects\n• Prior experience in consulting engineering\nContact: You want to be part of the Exyte team? We look forward to receiving your application!\nFor further questions and information, please do not hesitate to contact Tina Denny Tina.Denny@exyte.net\nPlease note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.\nExyte US, Inc. is proud to be an Affirmative Action and Equal Employment Opportunity employer that is committed to celebrating diversity and supporting an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance. We prohibit discrimination and harassment of any kind based on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexual orientation, gender identity or expression), national origin, disability status, genetic information, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.\n\n#J-18808-Ljbffr","company":"Exyte","rawCompany":"exyte","city":"Raleigh","state":"NC","isRemote":false,"isActive":true,"createdAt":"2026-06-17T04:12:00.322Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"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":"Senior API Process Engineer Small Molecules","description":"Description\nDiscover your exciting role The Lead Process Engineer will serve as the technical authority for process design and execution on EPC projects involving Active Pharmaceutical Ingredient (API) facilities, with a focus on small molecule drug substances. This role will lead process engineering activities across all project phases—conceptual design, FEED, detailed engineering, and construction insuring compliance with client specifications, regulatory standards, and project objectives.\nExplore your tasks and responsibilities Process Design Leadership: Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), material and energy balances, and equipment specifications for API small molecule facilities.\nProject Execution : Lead process engineering deliverables for EPC projects, including design basis documents, process narratives, and datasheets.\nRegulatory & cGMP Compliance: Ensure designs meet pharmaceutical regulatory requirements, including cGMP, FDA, EMA, and ICH guidelines.\nClient Interface: Act as the primary process engineering contact for clients, providing technical guidance and ensuring alignment with project goals.\nRisk & Safety Analysis: Conduct HAZOP, risk assessments, and ensure compliance with EHS standards.\nConstruction & Commissioning Support: Provide field engineering support during installation, commissioning, and start-up phases.\nTeam Leadership: Mentor junior engineers and coordinate with multi-disciplinary teams (mechanical, electrical, automation) to deliver integrated solutions.\nOther duties as assigned\nShow your expertise Minimum Requirements:\n\nEducation: Bachelor’s or Master’s degree in Chemical Engineering.\nExperience:\n• 10+ years in process engineering, with at least 5 years in EPC project execution for pharmaceutical or chemical facilities.\n• Strong background in API small molecule processes and facility design.\n• Professional Engineer (PE) License\n• Nation Council of Examiners for Engineering and Surveying (NCEES) Record\nTechnical Skills:\n• Proficiency in process simulation tools (Aspen Plus, HYSYS) and engineering standards.\n• Knowledge of cGMP, regulatory compliance, and cleanroom design principles.\nSoft Skills:\n• Strong leadership, communication, and client-facing skills.\n• Ability to manage multiple priorities in a fast-paced EPC environment.\nPreferred\n• Professional Engineer (PE) License preferred\n• Nation Council of Examiners for Engineering and Surveying (NCEES) Record preferred\n• Experience with modular construction and advanced manufacturing technologies\n• Familiarity with ISPE guidelines and QbD principles\n• Prior involvement in large-scale greenfield or brownfield pharmaceutical projects\n• Prior experience in consulting engineering\nContact: You want to be part of the Exyte team? We look forward to receiving your application!\nFor further questions and information, please do not hesitate to contact Tina Denny Tina.Denny@exyte.net\nPlease note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.\nExyte US, Inc. is proud to be an Affirmative Action and Equal Employment Opportunity employer that is committed to celebrating diversity and supporting an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance. We prohibit discrimination and harassment of any kind based on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexual orientation, gender identity or expression), national origin, disability status, genetic information, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:12:00.322Z","dateModified":"2026-06-17T04:12:00.322Z","hiringOrganization":{"@type":"Organization","name":"Exyte","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Raleigh","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"19eb8dfca78da88220f3ab3f"},"url":"https://jobsearcher.com/jobs/19eb8dfca78da88220f3ab3f"}}