{"schemaVersion":"jobsearcher.job.v1","id":"9b6eaa063c19cb39a46cb99a","url":"https://jobsearcher.com/jobs/9b6eaa063c19cb39a46cb99a","canonicalUrl":"https://jobsearcher.com/jobs/9b6eaa063c19cb39a46cb99a","title":"Principal Process Engineer - Pharma","description":"Job Title: Principal Process Engineer - PharmaLocation: Wilson, NCDuration: 12+ Months ContractPosition Summary:We are seeking experienced Principal Process Engineers to support a large-scale greenfield biologics manufacturing facility project in the Raleigh-Durham area. This role will serve as a technical owner for critical manufacturing systems, supporting the full project lifecycle from design and implementation through startup and operational readiness. This is a highly technical Process Engineering role focused on system ownership, process design, troubleshooting, startup, and technology transfer—not a CQV/Validation-focused position.Key Responsibilities:Serve as the Subject Matter Expert (SME) for manufacturing process systems.Support process design, equipment selection, and system optimization activities.Develop and review technical documentation including URS, FRS, and engineering documents.Support GMP facility startup, expansion, and technology transfer projects.Work closely with engineering firms, vendors, and project teams during design and construction phases.Lead commissioning, startup, and operational readiness activities.Provide hands-on troubleshooting and technical support during startup and manufacturing operations.Support downstream processing (DSP) manufacturing activities.Ensure manufacturing systems operate efficiently, reliably, and in compliance with GMP requirements.Participate in risk assessments, deviation investigations, and root cause analysis.Identify and implement process improvements to enhance performance and reliability.Collaborate with Manufacturing, Quality, Automation, Engineering, and external vendors.Provide technical leadership and support successful project execution across cross-functional teams.Required Qualifications:Bachelor's Degree in Engineering or related technical discipline.Minimum 5+ years of Process Engineering experience within a GMP-regulated manufacturing environment.Demonstrated experience supporting: Process design and implementation, Facility startup and commissioning, Large-scale capital projects, Complex process troubleshooting, Experience working in greenfield, brownfield, or major expansion projects.Strong understanding of GMP manufacturing processes and regulatory requirements.Hands-on experience with DeltaV automation systems.Required Technical Experience:Downstream Processing (DSP)Candidates should have strong experience with several of the following systems: Chromatography systems (AKTA, columns, purification skids), Ultrafiltration/Diafiltration (UF/DF) systems, Filtration systems (depth filtration, microfiltration, sterile filtration), Centrifuges, Product hold tanks and buffer hold tanks (single-use or stainless steel)Media and buffer preparation systems, Formulation systems and mixing vessels, Clean-In-Place (CIP) systems, Steam-In-Place (SIP) systems, Lyophilizers, Washers and autoclaves, Capping, inspection, and packaging systemsPreferred Qualifications:Advanced degree (MS, MBA, or PhD).Lean Manufacturing and/or Six Sigma experience.Experience supporting biologics manufacturing facilities.Experience leading large-scale startup and operational readiness initiatives.","company":"Intellectt","rawCompany":"intellectt","city":"Evansville","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-07-01T08:55:54.953Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Principal Process Engineer - Pharma","description":"Job Title: Principal Process Engineer - PharmaLocation: Wilson, NCDuration: 12+ Months ContractPosition Summary:We are seeking experienced Principal Process Engineers to support a large-scale greenfield biologics manufacturing facility project in the Raleigh-Durham area. This role will serve as a technical owner for critical manufacturing systems, supporting the full project lifecycle from design and implementation through startup and operational readiness. This is a highly technical Process Engineering role focused on system ownership, process design, troubleshooting, startup, and technology transfer—not a CQV/Validation-focused position.Key Responsibilities:Serve as the Subject Matter Expert (SME) for manufacturing process systems.Support process design, equipment selection, and system optimization activities.Develop and review technical documentation including URS, FRS, and engineering documents.Support GMP facility startup, expansion, and technology transfer projects.Work closely with engineering firms, vendors, and project teams during design and construction phases.Lead commissioning, startup, and operational readiness activities.Provide hands-on troubleshooting and technical support during startup and manufacturing operations.Support downstream processing (DSP) manufacturing activities.Ensure manufacturing systems operate efficiently, reliably, and in compliance with GMP requirements.Participate in risk assessments, deviation investigations, and root cause analysis.Identify and implement process improvements to enhance performance and reliability.Collaborate with Manufacturing, Quality, Automation, Engineering, and external vendors.Provide technical leadership and support successful project execution across cross-functional teams.Required Qualifications:Bachelor's Degree in Engineering or related technical discipline.Minimum 5+ years of Process Engineering experience within a GMP-regulated manufacturing environment.Demonstrated experience supporting: Process design and implementation, Facility startup and commissioning, Large-scale capital projects, Complex process troubleshooting, Experience working in greenfield, brownfield, or major expansion projects.Strong understanding of GMP manufacturing processes and regulatory requirements.Hands-on experience with DeltaV automation systems.Required Technical Experience:Downstream Processing (DSP)Candidates should have strong experience with several of the following systems: Chromatography systems (AKTA, columns, purification skids), Ultrafiltration/Diafiltration (UF/DF) systems, Filtration systems (depth filtration, microfiltration, sterile filtration), Centrifuges, Product hold tanks and buffer hold tanks (single-use or stainless steel)Media and buffer preparation systems, Formulation systems and mixing vessels, Clean-In-Place (CIP) systems, Steam-In-Place (SIP) systems, Lyophilizers, Washers and autoclaves, Capping, inspection, and packaging systemsPreferred Qualifications:Advanced degree (MS, MBA, or PhD).Lean Manufacturing and/or Six Sigma experience.Experience supporting biologics manufacturing facilities.Experience leading large-scale startup and operational readiness initiatives.","datePosted":"2026-07-01T08:55:54.953Z","dateModified":"2026-07-01T08:55:54.953Z","hiringOrganization":{"@type":"Organization","name":"Intellectt","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Evansville","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"9b6eaa063c19cb39a46cb99a"},"url":"https://jobsearcher.com/jobs/9b6eaa063c19cb39a46cb99a"}}