{"schemaVersion":"jobsearcher.job.v1","id":"12351cfd1cae3d12d31699bc","url":"https://jobsearcher.com/jobs/12351cfd1cae3d12d31699bc","canonicalUrl":"https://jobsearcher.com/jobs/12351cfd1cae3d12d31699bc","title":"Senior Validation Engineer","description":"Serán BioScience is motivated to find an industry‑experienced Validation Engineer to support the development of a new commercial manufacturing facility. The Senior Validation Engineer will be part of a cross‑functional team that will plan and execute commissioning/qualification (CQ) projects for equipment and critical utilities process, tech transfer of manufacturing process from clinical to commercial site, and subsequent validation for process, cleaning, and computerized systems to support commercial distribution of non‑sterile pharmaceutical products. Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams. Those with less experience are encouraged to apply.\n\nAs a critical member of the Commercial Steering Committee, the Senior Validation Engineer will be responsible for planning and execution of CQ and validation projects. In order to perform this task, applicants require a thorough understanding of the manufacturing processes and systems as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Successful candidates will understand that the development and execution of CQ and validation projects requires communication with internal and external cross‑functional teams. Demonstrated ability with effective communication is essential for identifying required information, alignment of strategies, and mitigation risks while maintaining good working relationships.\n\nDuties and Responsibilities\n\nLeads the commissioning and qualification (C&Q) of new and existing equipment and systems for OSD manufacturing, facilities, and utilities, ensuring compliance with cGMP, FDA, and EU regulatory standards\n\nSupports the clinical technology transfer and operations in design, scale‑up, optimization, and troubleshooting of OSD processes and equipment\n\nDevelops and executes protocols for equipment IQ/OQ/PQ in alignment with site validation master plans and project timelines\n\nCollaborates with cross‑functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgets\n\nManages installation activities, equipment FAT/SAT execution, and vendor coordination to ensure technical and compliance requirements are met\n\nCollaborates with multidisciplinary team to complete change controls, deviations investigations, and CAPAs as required\n\nSupports regulatory inspections and client audits\n\nPerforms other related duties as assigned\n\nResponsibilities may increase in scope to align with company initiatives\n\nRequired Skills and Abilities\n\nDemonstrates knowledge of cGMPs guidelines and regulations acquired through education, experience, and training\n\nPreference for those who posses knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA)\n\nShowcases foundational understanding of the compliance and technical requirements for the application of various scientific concepts used in developing different dosage forms of pharmaceutical products (primarily oral solid dose, while experience with sterile products is desired)\n\nExperience with regulatory expectations and industry practices for CQ and Validation using Product Lifecycle approach\n\nExperience with designing CQV plans for Facilities, Utilities, and Process equipment desired\n\nAbility to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross‑functional team\n\nStrong time‑management skills and the ability to organize and coordinate multiple projects at once\n\nCommunicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company\n\nAbility to prioritize tasks and to keep leadership apprised of performance timelines\n\nAccepts feedback from a variety of sources and constructively manages conflict\n\nDemonstrates leadership skills with ability to motivate and coach cross functional teams\n\nExperience in FAT/SAT of process equipment, and knowledge operating principles of typical OSD process equipment preferred.\n\nProficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems\n\nEducation and Experience\n\nBachelor's degree in relevant technical field\n\nRequires a minimum of 8 years of quality, validation, or engineering experience in non‑sterile clinical and commercial pharmaceutical manufacturing\n\nFundamental understanding of process equipment, utilities, manufacturing process, cleaning process and Quality systems used in the pharmaceutical/biotech industry\n\n8 years of GMP compliance experience, including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others\n\nPhysical Requirements\n\nProlonged periods of sitting or standing at a desk and working on a computer\n\nProlonged periods of sitting or standing in a manufacturing environment\n\nMust be able to lift fifteen pounds at times\n\nAdheres to consistent and predictable in‑person attendance\n\nVisit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.\n\nLevel and compensation will be based on experience.\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\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\nThe Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701.\n\n#J-18808-Ljbffr","company":"Seran Bioscience","rawCompany":"seran bioscience","city":"Sunriver","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-06-20T04:01:04.708Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"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":"Senior Validation Engineer","description":"Serán BioScience is motivated to find an industry‑experienced Validation Engineer to support the development of a new commercial manufacturing facility. The Senior Validation Engineer will be part of a cross‑functional team that will plan and execute commissioning/qualification (CQ) projects for equipment and critical utilities process, tech transfer of manufacturing process from clinical to commercial site, and subsequent validation for process, cleaning, and computerized systems to support commercial distribution of non‑sterile pharmaceutical products. Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams. Those with less experience are encouraged to apply.\n\nAs a critical member of the Commercial Steering Committee, the Senior Validation Engineer will be responsible for planning and execution of CQ and validation projects. In order to perform this task, applicants require a thorough understanding of the manufacturing processes and systems as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Successful candidates will understand that the development and execution of CQ and validation projects requires communication with internal and external cross‑functional teams. Demonstrated ability with effective communication is essential for identifying required information, alignment of strategies, and mitigation risks while maintaining good working relationships.\n\nDuties and Responsibilities\n\nLeads the commissioning and qualification (C&Q) of new and existing equipment and systems for OSD manufacturing, facilities, and utilities, ensuring compliance with cGMP, FDA, and EU regulatory standards\n\nSupports the clinical technology transfer and operations in design, scale‑up, optimization, and troubleshooting of OSD processes and equipment\n\nDevelops and executes protocols for equipment IQ/OQ/PQ in alignment with site validation master plans and project timelines\n\nCollaborates with cross‑functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgets\n\nManages installation activities, equipment FAT/SAT execution, and vendor coordination to ensure technical and compliance requirements are met\n\nCollaborates with multidisciplinary team to complete change controls, deviations investigations, and CAPAs as required\n\nSupports regulatory inspections and client audits\n\nPerforms other related duties as assigned\n\nResponsibilities may increase in scope to align with company initiatives\n\nRequired Skills and Abilities\n\nDemonstrates knowledge of cGMPs guidelines and regulations acquired through education, experience, and training\n\nPreference for those who posses knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA)\n\nShowcases foundational understanding of the compliance and technical requirements for the application of various scientific concepts used in developing different dosage forms of pharmaceutical products (primarily oral solid dose, while experience with sterile products is desired)\n\nExperience with regulatory expectations and industry practices for CQ and Validation using Product Lifecycle approach\n\nExperience with designing CQV plans for Facilities, Utilities, and Process equipment desired\n\nAbility to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross‑functional team\n\nStrong time‑management skills and the ability to organize and coordinate multiple projects at once\n\nCommunicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company\n\nAbility to prioritize tasks and to keep leadership apprised of performance timelines\n\nAccepts feedback from a variety of sources and constructively manages conflict\n\nDemonstrates leadership skills with ability to motivate and coach cross functional teams\n\nExperience in FAT/SAT of process equipment, and knowledge operating principles of typical OSD process equipment preferred.\n\nProficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems\n\nEducation and Experience\n\nBachelor's degree in relevant technical field\n\nRequires a minimum of 8 years of quality, validation, or engineering experience in non‑sterile clinical and commercial pharmaceutical manufacturing\n\nFundamental understanding of process equipment, utilities, manufacturing process, cleaning process and Quality systems used in the pharmaceutical/biotech industry\n\n8 years of GMP compliance experience, including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others\n\nPhysical Requirements\n\nProlonged periods of sitting or standing at a desk and working on a computer\n\nProlonged periods of sitting or standing in a manufacturing environment\n\nMust be able to lift fifteen pounds at times\n\nAdheres to consistent and predictable in‑person attendance\n\nVisit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.\n\nLevel and compensation will be based on experience.\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\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\nThe Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T04:01:04.708Z","dateModified":"2026-06-20T04:01:04.708Z","hiringOrganization":{"@type":"Organization","name":"Seran Bioscience","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sunriver","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"12351cfd1cae3d12d31699bc"},"url":"https://jobsearcher.com/jobs/12351cfd1cae3d12d31699bc"}}