{"schemaVersion":"jobsearcher.job.v1","id":"e7d4bfb586c138cd65b3a760","url":"https://jobsearcher.com/jobs/e7d4bfb586c138cd65b3a760","canonicalUrl":"https://jobsearcher.com/jobs/e7d4bfb586c138cd65b3a760","title":"Senior Validation Engineer","description":"Senior Validation Engineer – Job AX067-SF\nA senior level Validation Engineer needed for a permanent placement opportunity in the San Francisco Bay Area. The candidate will be part of the Cleaning/Sterilization Validation team, and will independently complete activities related to the items below:\nEnsuring all aspects of Cleaning and Sterilization Validation adhere to the customer’s global policies, procedures and guidelines, and external regulatory requirements;\nGenerating and executing validation protocols to demonstrate compliance to a standard suitable for review by internal and external auditors;\nAuthoring, Review and/or Oversight of cleaning and sterilization validation-related procedures, protocols and technical reports required;\nProviding product impact and root cause assessments on cleaning and sterilization related events and anticipated changes;\nDriving improvements in cleaning and sterilization validation.\nAreas of Responsibility\nPrimary source for cleaning and sterilization validation systems knowledge, including experience with Validation of steam in place (SIP) sterilization, autoclave sterilization, dry heat sterilization and sterilizing filtration. Responsible for validation-related activities, such as:\nDevelop sterilization re-validation programs, as appropriate;\nAccountable for compliance of the site sterilization validation program via documentation completion, risk assessments, proactive identification of risks /issues, review of protocols and reports, closure of preventative and corrective actions, and participation in audits and inspections;\nParticipate on investigation teams in the event of adverse sterilization validation trends/failures to identify root cause and corrective/preventative actions.\nFacilitates in problem solving & risk assessment (FMEA) projects/meetings;\nDevelop meaningful validation metrics/trending to enable continued drive for reliability and efficiency.\nQualifications\nAcademic degree in life sciences (biotechnology or related) or comparable level through experience;\nAt least 5 years of validation/ manufacturing experience, in a GMP setting. Preference for experience in biologics manufacturing (cell culture, purification);\nProven strong scientific, project & people management skills;\nStrong communicator and ability to build bridges between groups and organizations. Ability to create a team spirit;\nKnowledge of GMP guidelines and global validation expectations;\nCustomer focused, process oriented and data driven;","company":"Axis Consulting","rawCompany":"axis consulting","city":"Alameda","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-05T10:45:18.192Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"31-9093.00","title":"Medical Equipment Preparers","slug":"medical-equipment-preparers"}],"industries":[{"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"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Validation Engineer","description":"Senior Validation Engineer – Job AX067-SF\nA senior level Validation Engineer needed for a permanent placement opportunity in the San Francisco Bay Area. The candidate will be part of the Cleaning/Sterilization Validation team, and will independently complete activities related to the items below:\nEnsuring all aspects of Cleaning and Sterilization Validation adhere to the customer’s global policies, procedures and guidelines, and external regulatory requirements;\nGenerating and executing validation protocols to demonstrate compliance to a standard suitable for review by internal and external auditors;\nAuthoring, Review and/or Oversight of cleaning and sterilization validation-related procedures, protocols and technical reports required;\nProviding product impact and root cause assessments on cleaning and sterilization related events and anticipated changes;\nDriving improvements in cleaning and sterilization validation.\nAreas of Responsibility\nPrimary source for cleaning and sterilization validation systems knowledge, including experience with Validation of steam in place (SIP) sterilization, autoclave sterilization, dry heat sterilization and sterilizing filtration. Responsible for validation-related activities, such as:\nDevelop sterilization re-validation programs, as appropriate;\nAccountable for compliance of the site sterilization validation program via documentation completion, risk assessments, proactive identification of risks /issues, review of protocols and reports, closure of preventative and corrective actions, and participation in audits and inspections;\nParticipate on investigation teams in the event of adverse sterilization validation trends/failures to identify root cause and corrective/preventative actions.\nFacilitates in problem solving & risk assessment (FMEA) projects/meetings;\nDevelop meaningful validation metrics/trending to enable continued drive for reliability and efficiency.\nQualifications\nAcademic degree in life sciences (biotechnology or related) or comparable level through experience;\nAt least 5 years of validation/ manufacturing experience, in a GMP setting. Preference for experience in biologics manufacturing (cell culture, purification);\nProven strong scientific, project & people management skills;\nStrong communicator and ability to build bridges between groups and organizations. Ability to create a team spirit;\nKnowledge of GMP guidelines and global validation expectations;\nCustomer focused, process oriented and data driven;","datePosted":"2026-08-05T10:45:18.192Z","dateModified":"2026-08-05T10:45:18.192Z","hiringOrganization":{"@type":"Organization","name":"Axis Consulting","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Alameda","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e7d4bfb586c138cd65b3a760"},"url":"https://jobsearcher.com/jobs/e7d4bfb586c138cd65b3a760"}}