{"schemaVersion":"jobsearcher.job.v1","id":"e16891c1b1f749f357ec9289","url":"https://jobsearcher.com/jobs/e16891c1b1f749f357ec9289","canonicalUrl":"https://jobsearcher.com/jobs/e16891c1b1f749f357ec9289","title":"Process Engineer","description":"Serán BioScience is seeking a Process Engineer to play a critical role in facility start-up, commissioning of process systems, and operational readiness for our new commercial manufacturing operations. This position will ensure that all systems, equipment, and workflows are designed, installed, and commissioned to meet cGMP standards and support efficient, compliant production. Beyond the initial launch phase, this individual will be instrumental in sustaining manufacturing operations by driving long‑term operational excellence. This includes leading continuous improvement (CI) projects to ensure that all systems, equipment, and workflows remain efficient, compliant with cGMP standards, and capable of meeting evolving production demands.\n\nDuties and Responsibilities\nFacility & Process System Start‑Up\n\nLead design and engineering activities associated with process equipment for new installations and/or continuous improvements\n\nLead engineering activities for facility process systems through design, installation, and commissioning, including CIP, purified water, solvent distribution, and compressed gases\n\nOversee process equipment installation, commissioning, and qualification (URS, FAT, SAT, IQ/OQ/PQ)\n\nCoordinate with vendors and contractors to ensure timely and compliant start‑up of manufacturing systems\n\nDevelop and execute commissioning plans, risk assessments, and readiness checklists\n\nProcess Design & Optimization\n\nDesign and refine commercial‑scale manufacturing processes for oral solid dosage forms and enabling technologies\n\nPerform capacity analysis, cycle time studies, and throughput modeling to ensure production efficiency\n\nImplement Lean and Six Sigma methodologies to reduce waste and improve process reliability\n\nConduct formal risk assessments for existing process system to proactively mitigate quality and safety risks\n\nOperational Readiness\n\nDrive readiness activities for commercial launch, including supporting process validation and GMP documentation\n\nPartner with Validation, QA, and Manufacturing to ensure compliance with regulatory requirements\n\nSupport tech transfer from development to commercial scale\n\nCollaborate with the Facilities and Maintenance teams to establish preventive and predictive maintenance schedules for process systems\n\nDraft and review standard operating procedures (SOPs) for the operation, cleaning, and troubleshooting of new process systems\n\nContinuous Improvement\n\nAnalyze production data to identify bottlenecks and implement corrective actions\n\nDrive cost reduction initiatives and efficiency improvements without compromising quality\n\nParticipate in deviation investigations and CAPA implementation\n\nServe as the primary technical process system owner to ensure stable and robust manufacturing\n\nProject Management\n\nContribute to project timelines, resource planning, and budget adherence\n\nFacilitate cross‑functional project meetings and provide regular status updates to senior leadership\n\nProvide engineering input during client audits and regulatory inspections\n\nProactively identify project risks and implement mitigation strategies\n\nSkills, Abilities and Education Requirements\nRequired\n\nBS/MS in Industrial Engineering, Chemical Engineering, Mechanical Engineering, or related discipline\n\n8+ years of experience in pharmaceutical manufacturing, process engineering, or industrial engineering\n\nHands‑on experience with facility start‑up, commissioning, and equipment qualification\n\nStrong knowledge of cGMP requirements and commercial manufacturing operations\n\nProficiency in process modeling, workflow analysis, and Lean/Six Sigma tools\n\nExcellent communication and documentation skills\n\nPreferred\n\nExperience with oral solid dosage forms and enabling technologies (e.g., spray drying, blending, granulation, tableting, encapsulation, & tablet coating)\n\nFamiliarity with facility design for regulated environments\n\nKnowledge of ERP/MES systems and digital manufacturing tools\n\nProject engineering experience in a regulated industry\n\nCore Competencies\n\nAnalytical problem‑solving and data‑driven decision‑making\n\nAbility to work cross‑functionally in a fast‑paced environment\n\nStrong organizational skills and attention to detail\n\nContinuous improvement mindset\n\nPhysical Requirements\n\nProlonged periods of sitting or standing at a desk and working on a computer\n\nProlonged periods of sitting, standing, and moving throughout a manufacturing environment\n\nMust be able to lift fifteen pounds at times\n\nAdheres to consistent and predictable in‑person attendance\n\nBenefits Summary\nSerán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long‑term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.\n\nCompensation correlates to skills and experience presented by selected candidate.\n\nVisit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.\n\nApplicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.\n\nThe Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701.\n\n#J-18808-Ljbffr","company":"Medium","rawCompany":"medium","city":"Sunriver","state":"OR","isRemote":false,"isActive":true,"createdAt":"2026-06-20T03:45:46.223Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"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":"Serán BioScience is seeking a Process Engineer to play a critical role in facility start-up, commissioning of process systems, and operational readiness for our new commercial manufacturing operations. This position will ensure that all systems, equipment, and workflows are designed, installed, and commissioned to meet cGMP standards and support efficient, compliant production. Beyond the initial launch phase, this individual will be instrumental in sustaining manufacturing operations by driving long‑term operational excellence. This includes leading continuous improvement (CI) projects to ensure that all systems, equipment, and workflows remain efficient, compliant with cGMP standards, and capable of meeting evolving production demands.\n\nDuties and Responsibilities\nFacility & Process System Start‑Up\n\nLead design and engineering activities associated with process equipment for new installations and/or continuous improvements\n\nLead engineering activities for facility process systems through design, installation, and commissioning, including CIP, purified water, solvent distribution, and compressed gases\n\nOversee process equipment installation, commissioning, and qualification (URS, FAT, SAT, IQ/OQ/PQ)\n\nCoordinate with vendors and contractors to ensure timely and compliant start‑up of manufacturing systems\n\nDevelop and execute commissioning plans, risk assessments, and readiness checklists\n\nProcess Design & Optimization\n\nDesign and refine commercial‑scale manufacturing processes for oral solid dosage forms and enabling technologies\n\nPerform capacity analysis, cycle time studies, and throughput modeling to ensure production efficiency\n\nImplement Lean and Six Sigma methodologies to reduce waste and improve process reliability\n\nConduct formal risk assessments for existing process system to proactively mitigate quality and safety risks\n\nOperational Readiness\n\nDrive readiness activities for commercial launch, including supporting process validation and GMP documentation\n\nPartner with Validation, QA, and Manufacturing to ensure compliance with regulatory requirements\n\nSupport tech transfer from development to commercial scale\n\nCollaborate with the Facilities and Maintenance teams to establish preventive and predictive maintenance schedules for process systems\n\nDraft and review standard operating procedures (SOPs) for the operation, cleaning, and troubleshooting of new process systems\n\nContinuous Improvement\n\nAnalyze production data to identify bottlenecks and implement corrective actions\n\nDrive cost reduction initiatives and efficiency improvements without compromising quality\n\nParticipate in deviation investigations and CAPA implementation\n\nServe as the primary technical process system owner to ensure stable and robust manufacturing\n\nProject Management\n\nContribute to project timelines, resource planning, and budget adherence\n\nFacilitate cross‑functional project meetings and provide regular status updates to senior leadership\n\nProvide engineering input during client audits and regulatory inspections\n\nProactively identify project risks and implement mitigation strategies\n\nSkills, Abilities and Education Requirements\nRequired\n\nBS/MS in Industrial Engineering, Chemical Engineering, Mechanical Engineering, or related discipline\n\n8+ years of experience in pharmaceutical manufacturing, process engineering, or industrial engineering\n\nHands‑on experience with facility start‑up, commissioning, and equipment qualification\n\nStrong knowledge of cGMP requirements and commercial manufacturing operations\n\nProficiency in process modeling, workflow analysis, and Lean/Six Sigma tools\n\nExcellent communication and documentation skills\n\nPreferred\n\nExperience with oral solid dosage forms and enabling technologies (e.g., spray drying, blending, granulation, tableting, encapsulation, & tablet coating)\n\nFamiliarity with facility design for regulated environments\n\nKnowledge of ERP/MES systems and digital manufacturing tools\n\nProject engineering experience in a regulated industry\n\nCore Competencies\n\nAnalytical problem‑solving and data‑driven decision‑making\n\nAbility to work cross‑functionally in a fast‑paced environment\n\nStrong organizational skills and attention to detail\n\nContinuous improvement mindset\n\nPhysical Requirements\n\nProlonged periods of sitting or standing at a desk and working on a computer\n\nProlonged periods of sitting, standing, and moving throughout a manufacturing environment\n\nMust be able to lift fifteen pounds at times\n\nAdheres to consistent and predictable in‑person attendance\n\nBenefits Summary\nSerán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long‑term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.\n\nCompensation correlates to skills and experience presented by selected candidate.\n\nVisit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.\n\nApplicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.\n\nThe Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T03:45:46.223Z","dateModified":"2026-06-20T03:45:46.223Z","hiringOrganization":{"@type":"Organization","name":"Medium","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sunriver","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e16891c1b1f749f357ec9289"},"url":"https://jobsearcher.com/jobs/e16891c1b1f749f357ec9289"}}