{"schemaVersion":"jobsearcher.job.v1","id":"1ae83eb4423994c557ef7b49","url":"https://jobsearcher.com/jobs/1ae83eb4423994c557ef7b49","canonicalUrl":"https://jobsearcher.com/jobs/1ae83eb4423994c557ef7b49","title":"VALIDATION ENGINEER","description":"PRIMARY PURPOSE:\n\nFormulated Solutions is seeking a Validation Engineer to own system validation activities across the company. This role's initial and primary focus will be the validation of the eBR (electronic Batch Record) system as FS transitions manufacturing lines from paper batch records to eBR. The Validation Engineer will build and maintain the User Requirements Specification / Requirements Traceability Matrix (URS/RTM), coordinate the documentation and sign-off process across internal stakeholders and customers, and ensure that all validation work is complete, defensible, and audit-ready. This role will also lead the transition of FS's validation program off of Excel-based tracking and onto a dedicated validation management tool. As FS's validation program matures, this role will expand to cover validation of other systems and equipment across FS sites.\n\nMAJOR DUTIES AND RESPONSIBILITIES:\n\neBR Validation & URS/RTM Ownership\n\nOwn and maintain the URS/RTM (User Requirements Specification / Requirements Traceability Matrix) Excel workbook for eBR validation projects.\nReview existing paper batch records and work with Operations and Quality to capture and document the underlying requirements in the URS/RTM.\nTrace each captured requirement through to its corresponding test case and result, maintaining the RTM as the source of truth for requirement coverage.\nKeep the URS/RTM current as requirements change, and use it as the traceability backbone for validation testing and sign-off.\nLead the evaluation and adoption of a dedicated validation management tool, driving FS's transition away from Excel-based URS/RTM tracking toward a purpose-built system.\n\nValidation Documentation & Sign-Off\n\nOversee preparation of Management of Change (MOC) documentation and shepherd each MOC through internal and customer approval.\nOwn the Configuration Specification documentation for validated systems, ensuring it accurately reflects the as-built configuration.\nAuthor and manage the Validation Summary Report for each validation effort, consolidating testing results and open items.\nDraft User Acceptance Test (UAT) scripts, dry-run them internally ahead of formal execution, and lead execution of UATs with internal stakeholders and customers.\nTrack outstanding sign-offs across all validation documents and proactively follow up with internal approvers to keep projects moving.\n\nCustomer Coordination\n\nServe as a primary point of contact with customers (e.g., Bayer) on validation documentation and approvals.\nPackage and submit validation documentation to customers in the format and process they require, and follow up to obtain timely customer sign-off.\nCommunicate validation status, risks, and timelines clearly to both internal leadership and customer counterparts.\n\nBroader System Validation\n\nServe as the company-wide owner for system validation, extending validation practices beyond eBR to other systems and equipment as priorities dictate.\nPerform risk assessments and validation testing for system upgrades and patches to validated systems, ensuring continued compliance and audit-readiness.\nConduct internal periodic reviews of validated systems to confirm they remain in a validated state and to identify any drift requiring remediation.\nHelp establish and continuously improve FS's validation processes, templates, and standard practices.\nSupport internal and customer audits by ensuring validation documentation is organized, complete, and readily accessible.\n\nQUALIFICATION:\n\nRequired:\n\nBachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical field, or equivalent hands-on validation experience.\n3+ years of experience in validation or quality systems within a regulated manufacturing environment (pharmaceutical, consumer health, medical device, or similar GxP setting).\nWorking knowledge of computer system validation (CSV) / Computer Software Assurance (CSA) concepts and documentation — URS, risk assessment, Configuration Specification, IQ/OQ/PQ, and Validation Summary Reports.\nFamiliarity with data integrity principles (ALCOA+) and applicable regulations such as FDA 21 CFR Part 11 and cGMP.\nStrong Excel skills, with experience building and maintaining detailed tracking workbooks such as a URS/RTM.\n\nPreferred:\n\nDirect experience validating an electronic batch record (eBR) or MES platform (e.g., Tempo/Werum PAS-X or similar) in a manufacturing environment.\nExperience working directly with customers or external auditors on validation deliverables and sign-off.\nFamiliarity with Management of Change (MOC) / change control processes in a GxP environment.\nExperience in contract manufacturing or a multi-site manufacturing organization.\nExperience selecting, implementing, or administering a dedicated validation management or quality management software tool.\nExcellent written communication and documentation skills; comfortable authoring formal validation deliverables.\nStrong organizational skills and the ability to manage multiple documents, approvals, and stakeholders concurrently.","company":"Formulatedsolutions","rawCompany":"formulatedsolutions","city":"Largo","state":"FL","isRemote":false,"isActive":false,"createdAt":"2026-11-04T10:19:09.529Z","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":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"513210","title":"Software Publishers","slug":"software-publishers"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"VALIDATION ENGINEER","description":"PRIMARY PURPOSE:\n\nFormulated Solutions is seeking a Validation Engineer to own system validation activities across the company. This role's initial and primary focus will be the validation of the eBR (electronic Batch Record) system as FS transitions manufacturing lines from paper batch records to eBR. The Validation Engineer will build and maintain the User Requirements Specification / Requirements Traceability Matrix (URS/RTM), coordinate the documentation and sign-off process across internal stakeholders and customers, and ensure that all validation work is complete, defensible, and audit-ready. This role will also lead the transition of FS's validation program off of Excel-based tracking and onto a dedicated validation management tool. As FS's validation program matures, this role will expand to cover validation of other systems and equipment across FS sites.\n\nMAJOR DUTIES AND RESPONSIBILITIES:\n\neBR Validation & URS/RTM Ownership\n\nOwn and maintain the URS/RTM (User Requirements Specification / Requirements Traceability Matrix) Excel workbook for eBR validation projects.\nReview existing paper batch records and work with Operations and Quality to capture and document the underlying requirements in the URS/RTM.\nTrace each captured requirement through to its corresponding test case and result, maintaining the RTM as the source of truth for requirement coverage.\nKeep the URS/RTM current as requirements change, and use it as the traceability backbone for validation testing and sign-off.\nLead the evaluation and adoption of a dedicated validation management tool, driving FS's transition away from Excel-based URS/RTM tracking toward a purpose-built system.\n\nValidation Documentation & Sign-Off\n\nOversee preparation of Management of Change (MOC) documentation and shepherd each MOC through internal and customer approval.\nOwn the Configuration Specification documentation for validated systems, ensuring it accurately reflects the as-built configuration.\nAuthor and manage the Validation Summary Report for each validation effort, consolidating testing results and open items.\nDraft User Acceptance Test (UAT) scripts, dry-run them internally ahead of formal execution, and lead execution of UATs with internal stakeholders and customers.\nTrack outstanding sign-offs across all validation documents and proactively follow up with internal approvers to keep projects moving.\n\nCustomer Coordination\n\nServe as a primary point of contact with customers (e.g., Bayer) on validation documentation and approvals.\nPackage and submit validation documentation to customers in the format and process they require, and follow up to obtain timely customer sign-off.\nCommunicate validation status, risks, and timelines clearly to both internal leadership and customer counterparts.\n\nBroader System Validation\n\nServe as the company-wide owner for system validation, extending validation practices beyond eBR to other systems and equipment as priorities dictate.\nPerform risk assessments and validation testing for system upgrades and patches to validated systems, ensuring continued compliance and audit-readiness.\nConduct internal periodic reviews of validated systems to confirm they remain in a validated state and to identify any drift requiring remediation.\nHelp establish and continuously improve FS's validation processes, templates, and standard practices.\nSupport internal and customer audits by ensuring validation documentation is organized, complete, and readily accessible.\n\nQUALIFICATION:\n\nRequired:\n\nBachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical field, or equivalent hands-on validation experience.\n3+ years of experience in validation or quality systems within a regulated manufacturing environment (pharmaceutical, consumer health, medical device, or similar GxP setting).\nWorking knowledge of computer system validation (CSV) / Computer Software Assurance (CSA) concepts and documentation — URS, risk assessment, Configuration Specification, IQ/OQ/PQ, and Validation Summary Reports.\nFamiliarity with data integrity principles (ALCOA+) and applicable regulations such as FDA 21 CFR Part 11 and cGMP.\nStrong Excel skills, with experience building and maintaining detailed tracking workbooks such as a URS/RTM.\n\nPreferred:\n\nDirect experience validating an electronic batch record (eBR) or MES platform (e.g., Tempo/Werum PAS-X or similar) in a manufacturing environment.\nExperience working directly with customers or external auditors on validation deliverables and sign-off.\nFamiliarity with Management of Change (MOC) / change control processes in a GxP environment.\nExperience in contract manufacturing or a multi-site manufacturing organization.\nExperience selecting, implementing, or administering a dedicated validation management or quality management software tool.\nExcellent written communication and documentation skills; comfortable authoring formal validation deliverables.\nStrong organizational skills and the ability to manage multiple documents, approvals, and stakeholders concurrently.","datePosted":"2026-11-04T10:19:09.529Z","dateModified":"2026-11-04T10:19:09.529Z","hiringOrganization":{"@type":"Organization","name":"Formulatedsolutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Largo","addressRegion":"FL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"1ae83eb4423994c557ef7b49"},"url":"https://jobsearcher.com/jobs/1ae83eb4423994c557ef7b49"}}