{"schemaVersion":"jobsearcher.job.v1","id":"3b5b5c2e042251617638d631","url":"https://jobsearcher.com/jobs/3b5b5c2e042251617638d631","canonicalUrl":"https://jobsearcher.com/jobs/3b5b5c2e042251617638d631","title":"Sr Engineer- Process Development (CQV)","description":"Job Summary: We are seeking a highly skilled Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment . The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams.\nRoles & Responsibilities: Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes.\nAuthor, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).\nMaintain and manage Master Validation Plans and related documentation to ensure compliance with GMP and FDA regulations.\nServe as the technical SME for automated systems, labeling, and packaging process validation.\nCollaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure robust and validated systems supporting 24/7 production operations.\nConduct on-site and off-shift validation activities as needed to support continuous manufacturing operations.\nIdentify process gaps and recommend improvements to optimize validation and operational efficiency.\nSupport regulatory audits and inspections by providing accurate and complete validation documentation.\nEducation & Experience: Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field .\nProven experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated manufacturing environment .\nHands-on experience with automated and semi-automated equipment , labeling, and packaging operations.\nStrong knowledge of FDA regulations, GMP standards, and internal quality systems .\nExperience with validation documentation including Master Validation Plans, IQ/OQ/PQ protocols, and reports .\nFamiliarity with Kneat software is a plus.\nAbility to work flexible schedules, including on-site and off-shift validation activities .\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Newark","state":"OH","isRemote":false,"isActive":false,"createdAt":"2026-06-21T03:30:54.448Z","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":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr Engineer- Process Development (CQV)","description":"Job Summary: We are seeking a highly skilled Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment . The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams.\nRoles & Responsibilities: Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes.\nAuthor, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).\nMaintain and manage Master Validation Plans and related documentation to ensure compliance with GMP and FDA regulations.\nServe as the technical SME for automated systems, labeling, and packaging process validation.\nCollaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure robust and validated systems supporting 24/7 production operations.\nConduct on-site and off-shift validation activities as needed to support continuous manufacturing operations.\nIdentify process gaps and recommend improvements to optimize validation and operational efficiency.\nSupport regulatory audits and inspections by providing accurate and complete validation documentation.\nEducation & Experience: Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field .\nProven experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated manufacturing environment .\nHands-on experience with automated and semi-automated equipment , labeling, and packaging operations.\nStrong knowledge of FDA regulations, GMP standards, and internal quality systems .\nExperience with validation documentation including Master Validation Plans, IQ/OQ/PQ protocols, and reports .\nFamiliarity with Kneat software is a plus.\nAbility to work flexible schedules, including on-site and off-shift validation activities .\n\n#J-18808-Ljbffr","datePosted":"2026-06-21T03:30:54.448Z","dateModified":"2026-06-21T03:30:54.448Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Newark","addressRegion":"OH","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3b5b5c2e042251617638d631"},"url":"https://jobsearcher.com/jobs/3b5b5c2e042251617638d631"}}