{"schemaVersion":"jobsearcher.job.v1","id":"2cb96d2c97ec8e5efb9ada2f","url":"https://jobsearcher.com/jobs/2cb96d2c97ec8e5efb9ada2f","canonicalUrl":"https://jobsearcher.com/jobs/2cb96d2c97ec8e5efb9ada2f","title":"Validation Engineer","description":"Position Summary\nValidation engineer with experience in equipment, HVAC, utility and process qualification within a pharmaceutical industry. Previous plant experience is recommended. Background in aseptic processing, microbiology, environmental monitoring, chemistry, and production is recommended. The additional resources are requested for a total of fourteen (14) weeks starting in December 2017 and ending March 2018 to support Winter Shutdown changes. Hours can involve weekend or night shifts. Validation activities include writing system impact assessments, oversight of engineering during shutdown activities, execution of installation qualification, operational qualification, performance qualification, and summarizing qualification results/drafting qualification report summaries. The support staff must act in accordance with plant safety requirements, training and procedures.\n\nPosition Responsibilities\n\nSchedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.\n\nCoordinates and communicates all testing with affected functional groups and evaluates test results.\n\nExecutes equipment, facility, utility and computer system, Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.\n\nOversees and assists Engineers and/or Technicians with their assigned projects.\n\nProvides technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.\n\nThorough understanding of risk based validation, industry standards and best practices for validation.\n\nOrganizational Relationships\n\nWill interact with Shutdown stakeholders: Engineering, Operations, Quality, Safety, Planning, Contractors, etc.\n\nWeekly/daily meeting attendance as required.\n\nWill participate in team led by Pfizer group leaders.\n\nEducation and Experience\n\nEducation: BS/BA degree in science, engineering, manufacturing technology or closely related field or combination of education and work experience.\n\nExperience: Recommended minimum of 4 years pharmaceutical validation experience.\n\nTechnical Skills Requirements\n\nKnowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing.\n\nPhysical Position Requirements\n\nLogistics: Requires contractor to be on-site weekly with travel home every other weekend.\n\nMust be able and willing to work beyond office hours which may include weekends.\n\nRequires routine sitting, standing, walking, listening and talking.\n\nAcute mental and visual attention at all times.\n\nHandle multiple projects while managing frequent interruptions.\n\nRequires moderate lifting or moving up to 25 pounds (lbs.\n\n732-947-3452\n\n#J-18808-Ljbffr","company":"Pioneer Data Systems","rawCompany":"pioneer data systems","city":"Valley Falls","state":"KS","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:57:23.045Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"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":"Validation Engineer","description":"Position Summary\nValidation engineer with experience in equipment, HVAC, utility and process qualification within a pharmaceutical industry. Previous plant experience is recommended. Background in aseptic processing, microbiology, environmental monitoring, chemistry, and production is recommended. The additional resources are requested for a total of fourteen (14) weeks starting in December 2017 and ending March 2018 to support Winter Shutdown changes. Hours can involve weekend or night shifts. Validation activities include writing system impact assessments, oversight of engineering during shutdown activities, execution of installation qualification, operational qualification, performance qualification, and summarizing qualification results/drafting qualification report summaries. The support staff must act in accordance with plant safety requirements, training and procedures.\n\nPosition Responsibilities\n\nSchedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.\n\nCoordinates and communicates all testing with affected functional groups and evaluates test results.\n\nExecutes equipment, facility, utility and computer system, Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.\n\nOversees and assists Engineers and/or Technicians with their assigned projects.\n\nProvides technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.\n\nThorough understanding of risk based validation, industry standards and best practices for validation.\n\nOrganizational Relationships\n\nWill interact with Shutdown stakeholders: Engineering, Operations, Quality, Safety, Planning, Contractors, etc.\n\nWeekly/daily meeting attendance as required.\n\nWill participate in team led by Pfizer group leaders.\n\nEducation and Experience\n\nEducation: BS/BA degree in science, engineering, manufacturing technology or closely related field or combination of education and work experience.\n\nExperience: Recommended minimum of 4 years pharmaceutical validation experience.\n\nTechnical Skills Requirements\n\nKnowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing.\n\nPhysical Position Requirements\n\nLogistics: Requires contractor to be on-site weekly with travel home every other weekend.\n\nMust be able and willing to work beyond office hours which may include weekends.\n\nRequires routine sitting, standing, walking, listening and talking.\n\nAcute mental and visual attention at all times.\n\nHandle multiple projects while managing frequent interruptions.\n\nRequires moderate lifting or moving up to 25 pounds (lbs.\n\n732-947-3452\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:57:23.045Z","dateModified":"2026-07-16T03:57:23.045Z","hiringOrganization":{"@type":"Organization","name":"Pioneer Data Systems","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Valley Falls","addressRegion":"KS","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2cb96d2c97ec8e5efb9ada2f"},"url":"https://jobsearcher.com/jobs/2cb96d2c97ec8e5efb9ada2f"}}