{"schemaVersion":"jobsearcher.job.v1","id":"a4327fb5b75379729ec7deb5","url":"https://jobsearcher.com/jobs/a4327fb5b75379729ec7deb5","canonicalUrl":"https://jobsearcher.com/jobs/a4327fb5b75379729ec7deb5","title":"Senior Validation Engineer","description":"Sr. Validation Engineer\nClinton, TN | Full-time\n\nAt least one year of experience in a Pharmaceutical GMP setting is required for consideration.\n\nAbout Alcami\nAlcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle.\n\nSummary of the Role\nThis role is responsible for leading validation and qualification activities that support compliant pharmaceutical packaging operations, including packaging equipment, utilities, facilities, and computerized systems. The Sr. Validation Specialist develops and executes validation protocols, maintains validation documentation, manages change controls, and ensures systems remain inspection‑ready and compliant with cGMP, data integrity, and 21 CFR Part 11 requirements. The position partners closely with engineering, quality, operations, IT, contractors, and equipment vendors to support the installation, qualification, and ongoing performance of packaging‑related equipment and systems. Additionally, the role serves as a validation subject matter expert during audits, provides technical guidance, authors SOPs and validation plans, and helps drive continuous compliance across packaging and operational processes.\n\nYour Expectations\nValidation & Qualification\n\nPartner with Engineering, Operations, Quality, IT, vendors, and contractors on qualification and validation initiatives.\n\nSupport the planning, installation, startup, and validation of new or updated equipment and systems.\n\nServe as the primary validation resource for contractors and external service providers.\n\nAnalyze complex technical and compliance issues and recommend effective solutions.\n\nValidation Program Management\n\nDevelop validation procedures, protocols, and project plans to support business and compliance objectives.\n\nMaintain qualification and validation documentation, ensuring accuracy, completeness, and audit readiness.\n\nAuthor and revise SOPs and Master Validation Plans (MVPs).\n\nManage ongoing validation lifecycle activities, including change controls and periodic system reviews.\n\nCross Functional Project Support\n\nPartner with Engineering, Operations, Quality, IT, vendors, and contractors on qualification and validation initiatives.\n\nSupport the planning, installation, startup, and validation of new or updated equipment and systems.\n\nServe as the primary validation resource for contractors and external service providers.\n\nAnalyze complex technical and compliance issues and recommend effective solutions.\n\nCompliance, Training, & Technical Leadership\n\nEnsure validation activities are conducted in accordance with cGMP requirements and internal quality standards.\n\nExercise technical judgment to resolve validation and compliance‑related challenges.\n\nAct as a certified trainer and support validation‑related training programs.\n\nProvide subject matter expertise on validation practices, compliance requirements, and system qualification strategies.\n\nRequirements\n\nBachelor's degree in Engineering, Chemistry, Biology, or related field is required.\n\nAt least one year of experience in a Pharmaceutical cGMP Manufacturing setting is required.\n\nMinimum 10 years of experience in a regulated manufacturing environment, preferably pharmaceutical, biotech, medical device, or consumer healthcare packaging.\n\nExperience qualifying and validating equipment, utilities, and computerized systems within a cGMP‑regulated pharmaceutical, biotech, medical device, or packaging environment.\n\nProven ability to lead validation projects, support new equipment implementation, manage change controls, and maintain systems in a validated state throughout their lifecycle.\n\nStrong analytical skills with the ability to work effectively across Engineering, Quality, Operations, IT, and external vendors to resolve complex technical and compliance challenges.\n\nProficiency with Microsoft Office Suite (Word, Excel, PowerPoint) required; experience with project management and scheduling tools preferred.\n\nStrong technical, analytical, and problem‑solving skills with the ability to manage multiple priorities in a fast‑paced environment.\n\nExcellent communication, presentation, and stakeholder management skills with the ability to collaborate effectively across all levels of the organization.\n\nAll Offers are conditional pending successful completion of Tjoapack’s Pre-Employment Drug Screening, Physical Examination, and Background Check.\n\n#J-18808-Ljbffr","company":"Socket","rawCompany":"socket","city":"Clinton","state":"TN","isRemote":false,"isActive":false,"createdAt":"2026-09-09T03:14:19.993Z","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":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"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":"Sr. Validation Engineer\nClinton, TN | Full-time\n\nAt least one year of experience in a Pharmaceutical GMP setting is required for consideration.\n\nAbout Alcami\nAlcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle.\n\nSummary of the Role\nThis role is responsible for leading validation and qualification activities that support compliant pharmaceutical packaging operations, including packaging equipment, utilities, facilities, and computerized systems. The Sr. Validation Specialist develops and executes validation protocols, maintains validation documentation, manages change controls, and ensures systems remain inspection‑ready and compliant with cGMP, data integrity, and 21 CFR Part 11 requirements. The position partners closely with engineering, quality, operations, IT, contractors, and equipment vendors to support the installation, qualification, and ongoing performance of packaging‑related equipment and systems. Additionally, the role serves as a validation subject matter expert during audits, provides technical guidance, authors SOPs and validation plans, and helps drive continuous compliance across packaging and operational processes.\n\nYour Expectations\nValidation & Qualification\n\nPartner with Engineering, Operations, Quality, IT, vendors, and contractors on qualification and validation initiatives.\n\nSupport the planning, installation, startup, and validation of new or updated equipment and systems.\n\nServe as the primary validation resource for contractors and external service providers.\n\nAnalyze complex technical and compliance issues and recommend effective solutions.\n\nValidation Program Management\n\nDevelop validation procedures, protocols, and project plans to support business and compliance objectives.\n\nMaintain qualification and validation documentation, ensuring accuracy, completeness, and audit readiness.\n\nAuthor and revise SOPs and Master Validation Plans (MVPs).\n\nManage ongoing validation lifecycle activities, including change controls and periodic system reviews.\n\nCross Functional Project Support\n\nPartner with Engineering, Operations, Quality, IT, vendors, and contractors on qualification and validation initiatives.\n\nSupport the planning, installation, startup, and validation of new or updated equipment and systems.\n\nServe as the primary validation resource for contractors and external service providers.\n\nAnalyze complex technical and compliance issues and recommend effective solutions.\n\nCompliance, Training, & Technical Leadership\n\nEnsure validation activities are conducted in accordance with cGMP requirements and internal quality standards.\n\nExercise technical judgment to resolve validation and compliance‑related challenges.\n\nAct as a certified trainer and support validation‑related training programs.\n\nProvide subject matter expertise on validation practices, compliance requirements, and system qualification strategies.\n\nRequirements\n\nBachelor's degree in Engineering, Chemistry, Biology, or related field is required.\n\nAt least one year of experience in a Pharmaceutical cGMP Manufacturing setting is required.\n\nMinimum 10 years of experience in a regulated manufacturing environment, preferably pharmaceutical, biotech, medical device, or consumer healthcare packaging.\n\nExperience qualifying and validating equipment, utilities, and computerized systems within a cGMP‑regulated pharmaceutical, biotech, medical device, or packaging environment.\n\nProven ability to lead validation projects, support new equipment implementation, manage change controls, and maintain systems in a validated state throughout their lifecycle.\n\nStrong analytical skills with the ability to work effectively across Engineering, Quality, Operations, IT, and external vendors to resolve complex technical and compliance challenges.\n\nProficiency with Microsoft Office Suite (Word, Excel, PowerPoint) required; experience with project management and scheduling tools preferred.\n\nStrong technical, analytical, and problem‑solving skills with the ability to manage multiple priorities in a fast‑paced environment.\n\nExcellent communication, presentation, and stakeholder management skills with the ability to collaborate effectively across all levels of the organization.\n\nAll Offers are conditional pending successful completion of Tjoapack’s Pre-Employment Drug Screening, Physical Examination, and Background Check.\n\n#J-18808-Ljbffr","datePosted":"2026-09-09T03:14:19.993Z","dateModified":"2026-09-09T03:14:19.993Z","hiringOrganization":{"@type":"Organization","name":"Socket","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Clinton","addressRegion":"TN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a4327fb5b75379729ec7deb5"},"url":"https://jobsearcher.com/jobs/a4327fb5b75379729ec7deb5"}}