{"schemaVersion":"jobsearcher.job.v1","id":"11131f7f2bfebbfe4bc1b901","url":"https://jobsearcher.com/jobs/11131f7f2bfebbfe4bc1b901","canonicalUrl":"https://jobsearcher.com/jobs/11131f7f2bfebbfe4bc1b901","title":"Process Engineer (Process Validation / PPQ Readiness)","description":"Process Engineer (Process Validation / PPQ Readiness)Location: Sanford, NC (Onsite)Duration: Approximately 9 MonthsPosition SummaryOur client is seeking an experienced Process Engineer to support process validation and Process Performance Qualification (PPQ) readiness activities at a biopharmaceutical manufacturing facility in Sanford, NC. This role will focus on validation strategy development, protocol authorship, qualification planning, and cross-functional execution support to ensure successful PPQ implementation and GMP compliance.The successful candidate will work closely with Manufacturing, Quality, Engineering, and Validation teams to drive process qualification activities, manage validation studies, and support issue resolution throughout project execution.ResponsibilitiesAssess current process validation activities and identify gaps requiring remediation.Develop process validation strategies, action plans, and implementation roadmaps.Author validation protocols, reports, and supporting GMP documentation.Develop qualification strategies for:Solution mixing operationsProcess hold studiesIn-process hold qualificationsContainer hold studiesDevelop airflow visualization (AFV) study strategies for Grade A Biological Safety Cabinets.Coordinate and track execution of process qualification and validation activities.Manage scheduling, documentation, and execution support for hold studies and related validation efforts.Review Process FMEA outputs and support alignment of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).Partner with Manufacturing, Quality, Engineering, and Subject Matter Experts to ensure successful execution of qualification activities.Participate in project meetings and support validation planning, issue management, and readiness efforts.Required QualificationsBachelor's degree in Engineering or related technical discipline.Experience supporting process validation and PPQ readiness within a biopharmaceutical or pharmaceutical manufacturing environment.Strong technical writing experience, including protocol and report authorship.Experience coordinating qualification studies and validation execution activities.Working knowledge of:GMP regulations and compliance requirementsProcess validation principlesRisk assessment methodologies, including FMEAStrong organizational, communication, and cross-functional collaboration skills.Preferred QualificationsExperience supporting biologics manufacturing operations.Experience with process hold studies, container hold studies, and mixing qualifications.Familiarity with airflow visualization (AFV) studies within aseptic manufacturing environments.Experience working in FDA-regulated manufacturing facilities.","company":"Vtek Systems","rawCompany":"vtek systems","city":"Sanford","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-08-15T10:26:48.248Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"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":"Process Engineer (Process Validation / PPQ Readiness)","description":"Process Engineer (Process Validation / PPQ Readiness)Location: Sanford, NC (Onsite)Duration: Approximately 9 MonthsPosition SummaryOur client is seeking an experienced Process Engineer to support process validation and Process Performance Qualification (PPQ) readiness activities at a biopharmaceutical manufacturing facility in Sanford, NC. This role will focus on validation strategy development, protocol authorship, qualification planning, and cross-functional execution support to ensure successful PPQ implementation and GMP compliance.The successful candidate will work closely with Manufacturing, Quality, Engineering, and Validation teams to drive process qualification activities, manage validation studies, and support issue resolution throughout project execution.ResponsibilitiesAssess current process validation activities and identify gaps requiring remediation.Develop process validation strategies, action plans, and implementation roadmaps.Author validation protocols, reports, and supporting GMP documentation.Develop qualification strategies for:Solution mixing operationsProcess hold studiesIn-process hold qualificationsContainer hold studiesDevelop airflow visualization (AFV) study strategies for Grade A Biological Safety Cabinets.Coordinate and track execution of process qualification and validation activities.Manage scheduling, documentation, and execution support for hold studies and related validation efforts.Review Process FMEA outputs and support alignment of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).Partner with Manufacturing, Quality, Engineering, and Subject Matter Experts to ensure successful execution of qualification activities.Participate in project meetings and support validation planning, issue management, and readiness efforts.Required QualificationsBachelor's degree in Engineering or related technical discipline.Experience supporting process validation and PPQ readiness within a biopharmaceutical or pharmaceutical manufacturing environment.Strong technical writing experience, including protocol and report authorship.Experience coordinating qualification studies and validation execution activities.Working knowledge of:GMP regulations and compliance requirementsProcess validation principlesRisk assessment methodologies, including FMEAStrong organizational, communication, and cross-functional collaboration skills.Preferred QualificationsExperience supporting biologics manufacturing operations.Experience with process hold studies, container hold studies, and mixing qualifications.Familiarity with airflow visualization (AFV) studies within aseptic manufacturing environments.Experience working in FDA-regulated manufacturing facilities.","datePosted":"2026-08-15T10:26:48.248Z","dateModified":"2026-08-15T10:26:48.248Z","hiringOrganization":{"@type":"Organization","name":"Vtek Systems","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sanford","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"11131f7f2bfebbfe4bc1b901"},"url":"https://jobsearcher.com/jobs/11131f7f2bfebbfe4bc1b901"}}