{"schemaVersion":"jobsearcher.job.v1","id":"7a4ed391859f027e05fed00a","url":"https://jobsearcher.com/jobs/7a4ed391859f027e05fed00a","canonicalUrl":"https://jobsearcher.com/jobs/7a4ed391859f027e05fed00a","title":"Validation Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:\nValidation Engineer\nDescription:\nWe are seeking a Validation Engineer with hands-on experience in biotech/pharmaceutical manufacturing, specifically supporting aseptic filling operations (vials). This role will be responsible for executing and supporting validation activities for equipment, processes, and computerized systems in compliance with regulatory requirements and industry standards.\nResponsibilities:\nDevelop, review, and execute validation protocols including IQ, OQ, PQ for:\nAseptic filling lines (vial filling, stoppering, capping)\nLyophilization (if applicable)\nSupport equipment (autoclaves, washers, depyrogenation tunnels)\nPerform process validation activities related to sterile manufacturing, including media fills (APS).\nEnsure compliance with cGMP, FDA, EMA, and ICH guidelines.\nSupport commissioning and qualification (C&Q) activities for new equipment and facility upgrades.\nGenerate and review:\nValidation master plans (VMPs)\nSOPs, protocols, and final reports\nCollaborate with cross-functional teams (Manufacturing, QA, Engineering, MSAT).\nInvestigate deviations, CAPAs, and implement corrective actions related to validation activities.\nSupport risk assessments (FMEA, impact assessments) for validation scope.\nEnsure data integrity and adherence to 21 CFR Part 11 requirements (if applicable to systems).\nQualifications:\nBachelor’s degree in Engineering, Chemistry, Biology, or related field.\n3–7+ years of validation experience in biotech or pharmaceutical industry.\nStrong experience with:\nAseptic processing\nVial filling operations\nSterile manufacturing environments\nMust be fully bilingual (English / Spanish) with excellent oral skills.\nMust be proficient using MS Windows and Microsoft Office applications.\nStrong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.\nExperience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.\nAvailable to work extended hours, possibility of weekends and holidays.\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","company":"Validation","rawCompany":"validation","city":"Westfield","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-04-14T11:25:17.295Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"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":"Validation Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:\nValidation Engineer\nDescription:\nWe are seeking a Validation Engineer with hands-on experience in biotech/pharmaceutical manufacturing, specifically supporting aseptic filling operations (vials). This role will be responsible for executing and supporting validation activities for equipment, processes, and computerized systems in compliance with regulatory requirements and industry standards.\nResponsibilities:\nDevelop, review, and execute validation protocols including IQ, OQ, PQ for:\nAseptic filling lines (vial filling, stoppering, capping)\nLyophilization (if applicable)\nSupport equipment (autoclaves, washers, depyrogenation tunnels)\nPerform process validation activities related to sterile manufacturing, including media fills (APS).\nEnsure compliance with cGMP, FDA, EMA, and ICH guidelines.\nSupport commissioning and qualification (C&Q) activities for new equipment and facility upgrades.\nGenerate and review:\nValidation master plans (VMPs)\nSOPs, protocols, and final reports\nCollaborate with cross-functional teams (Manufacturing, QA, Engineering, MSAT).\nInvestigate deviations, CAPAs, and implement corrective actions related to validation activities.\nSupport risk assessments (FMEA, impact assessments) for validation scope.\nEnsure data integrity and adherence to 21 CFR Part 11 requirements (if applicable to systems).\nQualifications:\nBachelor’s degree in Engineering, Chemistry, Biology, or related field.\n3–7+ years of validation experience in biotech or pharmaceutical industry.\nStrong experience with:\nAseptic processing\nVial filling operations\nSterile manufacturing environments\nMust be fully bilingual (English / Spanish) with excellent oral skills.\nMust be proficient using MS Windows and Microsoft Office applications.\nStrong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.\nExperience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.\nAvailable to work extended hours, possibility of weekends and holidays.\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","datePosted":"2026-04-14T11:25:17.295Z","dateModified":"2026-04-14T11:25:17.295Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Westfield","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7a4ed391859f027e05fed00a"},"url":"https://jobsearcher.com/jobs/7a4ed391859f027e05fed00a"}}