{"schemaVersion":"jobsearcher.job.v1","id":"26d3ef13641b4d17d8a76fa6","url":"https://jobsearcher.com/jobs/26d3ef13641b4d17d8a76fa6","canonicalUrl":"https://jobsearcher.com/jobs/26d3ef13641b4d17d8a76fa6","title":"Quality Engineer","description":"Job Title: Engineering Deviation Investigator (GMP Sterile Injectable Manufacturing)Location: Kenosha, WI (Onsite)Duration: 3‑month contractStart Date: ASAPOpenings: 2Company: Brooksource Engineering ServicesPosition OverviewBrooksource Engineering Services is seeking two Engineering Deviation Investigation resources to support a GMP‑regulated sterile injectable manufacturing site in Kenosha, Wisconsin. These engineers will play a critical role in the site’s quality system by leading and authoring technical investigations, supporting deviation review boards, and driving corrective and preventive actions within a regulated manufacturing environment.This is a short‑term, high‑impact engagement requiring immediate onboarding and hands‑on experience in deviation investigation and electronic quality management systems.Key ResponsibilitiesAuthor and manage technical investigations for deviations using formal root cause analysis tools (e.g., 5‑Why, 6M, Fishbone).Collaborate closely with site subject matter experts to gather data, technical information, and facts to support investigations.Execute investigation records directly within an electronic Quality Management System (Veeva QMS or comparable system).Prepare and present investigation summaries for Moderate and Major deviations at Deviation Review Board meetings.Partner with site SMEs to define, open, and document CAPAs within the QMS.Support CAPA implementation activities, including coordination of document updates, routing approvals, and status tracking within Veeva (as time allows).Minimum QualificationsEngineering background (e.g., Chemical, Mechanical, Industrial, Bioengineering, or similar).Minimum of 3 years of experience in a regulated manufacturing environment such as pharmaceutical (injectables preferred), medical device, topical products, food, or cosmetics.Strong working knowledge of GMP, GDP, and 21 CFR Parts 210 and 211.Minimum of 1 year of hands‑on deviation investigation writing experience.Direct experience working in Veeva QMS or a comparable electronic quality management system.Ability to work onsite in a sterile manufacturing environment.Strong technical writing skills and the ability to synthesize complex information clearly and concisely.Nice to HaveExperience supporting sterile injectable manufacturing or aseptic processing environments.Prior participation in Deviation Review Boards or similar quality governance forums.Exposure to CAPA effectiveness checks and closure activities.","company":"Brooksource","rawCompany":"brooksource","city":"Kenosha","state":"WI","isRemote":false,"isActive":false,"createdAt":"2026-04-19T03:06:34.033Z","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":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Job Title: Engineering Deviation Investigator (GMP Sterile Injectable Manufacturing)Location: Kenosha, WI (Onsite)Duration: 3‑month contractStart Date: ASAPOpenings: 2Company: Brooksource Engineering ServicesPosition OverviewBrooksource Engineering Services is seeking two Engineering Deviation Investigation resources to support a GMP‑regulated sterile injectable manufacturing site in Kenosha, Wisconsin. These engineers will play a critical role in the site’s quality system by leading and authoring technical investigations, supporting deviation review boards, and driving corrective and preventive actions within a regulated manufacturing environment.This is a short‑term, high‑impact engagement requiring immediate onboarding and hands‑on experience in deviation investigation and electronic quality management systems.Key ResponsibilitiesAuthor and manage technical investigations for deviations using formal root cause analysis tools (e.g., 5‑Why, 6M, Fishbone).Collaborate closely with site subject matter experts to gather data, technical information, and facts to support investigations.Execute investigation records directly within an electronic Quality Management System (Veeva QMS or comparable system).Prepare and present investigation summaries for Moderate and Major deviations at Deviation Review Board meetings.Partner with site SMEs to define, open, and document CAPAs within the QMS.Support CAPA implementation activities, including coordination of document updates, routing approvals, and status tracking within Veeva (as time allows).Minimum QualificationsEngineering background (e.g., Chemical, Mechanical, Industrial, Bioengineering, or similar).Minimum of 3 years of experience in a regulated manufacturing environment such as pharmaceutical (injectables preferred), medical device, topical products, food, or cosmetics.Strong working knowledge of GMP, GDP, and 21 CFR Parts 210 and 211.Minimum of 1 year of hands‑on deviation investigation writing experience.Direct experience working in Veeva QMS or a comparable electronic quality management system.Ability to work onsite in a sterile manufacturing environment.Strong technical writing skills and the ability to synthesize complex information clearly and concisely.Nice to HaveExperience supporting sterile injectable manufacturing or aseptic processing environments.Prior participation in Deviation Review Boards or similar quality governance forums.Exposure to CAPA effectiveness checks and closure activities.","datePosted":"2026-04-19T03:06:34.033Z","dateModified":"2026-04-19T03:06:34.033Z","hiringOrganization":{"@type":"Organization","name":"Brooksource","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Kenosha","addressRegion":"WI","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"26d3ef13641b4d17d8a76fa6"},"url":"https://jobsearcher.com/jobs/26d3ef13641b4d17d8a76fa6"}}