{"schemaVersion":"jobsearcher.job.v1","id":"ca7eda1f6acbdcc981efed4c","url":"https://jobsearcher.com/jobs/ca7eda1f6acbdcc981efed4c","canonicalUrl":"https://jobsearcher.com/jobs/ca7eda1f6acbdcc981efed4c","title":"Validation Engineer","description":"Validation EngineerLocation: INJob Type: ContractDuration: 12 MonthsJob SummaryWe are seeking an experienced Validation Engineer to support validation activities within a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. The engineer will be responsible for developing, executing, and documenting validation activities in compliance with GxP, cGMP, FDA, and applicable industry standards.Key ResponsibilitiesDevelop and execute validation protocols, including IQ, OQ, PQ, and process validation.Prepare and review validation plans, protocols, reports, and supporting documentation.Support equipment, facility, utility, process, and cleaning validation activities.Execute qualification and validation activities for manufacturing and laboratory equipment.Perform protocol execution, data collection, deviation documentation, and validation report generation.Investigate validation-related deviations, discrepancies, and out-of-specification results.Support change controls, CAPA, risk assessments, and impact assessments.Work closely with Engineering, Manufacturing, Quality Assurance, Automation, and Maintenance teams.Ensure validation documentation complies with cGMP, FDA, GAMP 5, and company procedures.Participate in commissioning and qualification activities and provide technical support during equipment start-up.Maintain accurate and audit-ready validation records.Support internal and external regulatory inspections and audits when required.Required QualificationsBachelor's degree in Engineering, Life Sciences, Chemistry, or a related technical field.3+ years of experience in validation/qualification within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.Hands-on experience with IQ/OQ/PQ and validation documentation.Strong understanding of GMP/cGMP and FDA regulations.Experience with deviations, change controls, CAPA, and risk assessments.Strong technical writing and documentation skills.Ability to work effectively in a cross-functional team environment.Preferred QualificationsExperience with process validation, equipment qualification, cleaning validation, or facility/utilities validation.Knowledge of 21 CFR Part 11, GAMP 5, ASTM E2500, and ISPE guidelines.Experience with computerized systems or automation validation is a plus.Experience working with DeltaV, PLC/SCADA systems, LIMS, MES, or other GMP computerized systems is preferred.Experience supporting commissioning and start-up activities.Familiarity with electronic validation/document management systems.","company":"Shoolin","rawCompany":"shoolin","city":"South Bend","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-08-14T14:52:37.082Z","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":"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":"Validation Engineer","description":"Validation EngineerLocation: INJob Type: ContractDuration: 12 MonthsJob SummaryWe are seeking an experienced Validation Engineer to support validation activities within a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. The engineer will be responsible for developing, executing, and documenting validation activities in compliance with GxP, cGMP, FDA, and applicable industry standards.Key ResponsibilitiesDevelop and execute validation protocols, including IQ, OQ, PQ, and process validation.Prepare and review validation plans, protocols, reports, and supporting documentation.Support equipment, facility, utility, process, and cleaning validation activities.Execute qualification and validation activities for manufacturing and laboratory equipment.Perform protocol execution, data collection, deviation documentation, and validation report generation.Investigate validation-related deviations, discrepancies, and out-of-specification results.Support change controls, CAPA, risk assessments, and impact assessments.Work closely with Engineering, Manufacturing, Quality Assurance, Automation, and Maintenance teams.Ensure validation documentation complies with cGMP, FDA, GAMP 5, and company procedures.Participate in commissioning and qualification activities and provide technical support during equipment start-up.Maintain accurate and audit-ready validation records.Support internal and external regulatory inspections and audits when required.Required QualificationsBachelor's degree in Engineering, Life Sciences, Chemistry, or a related technical field.3+ years of experience in validation/qualification within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.Hands-on experience with IQ/OQ/PQ and validation documentation.Strong understanding of GMP/cGMP and FDA regulations.Experience with deviations, change controls, CAPA, and risk assessments.Strong technical writing and documentation skills.Ability to work effectively in a cross-functional team environment.Preferred QualificationsExperience with process validation, equipment qualification, cleaning validation, or facility/utilities validation.Knowledge of 21 CFR Part 11, GAMP 5, ASTM E2500, and ISPE guidelines.Experience with computerized systems or automation validation is a plus.Experience working with DeltaV, PLC/SCADA systems, LIMS, MES, or other GMP computerized systems is preferred.Experience supporting commissioning and start-up activities.Familiarity with electronic validation/document management systems.","datePosted":"2026-08-14T14:52:37.082Z","dateModified":"2026-08-14T14:52:37.082Z","hiringOrganization":{"@type":"Organization","name":"Shoolin","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"South Bend","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ca7eda1f6acbdcc981efed4c"},"url":"https://jobsearcher.com/jobs/ca7eda1f6acbdcc981efed4c"}}