Manufacturing Engineer

Manufacturing Engineer (Pharma / Medical Device)Location:Virginia - W2Delaware (12 Months – FDA 483 Remediation)Job SummaryWe are seeking experienced Manufacturing Engineers to support pharmaceutical and FDA-regulated medical device manufacturing operations. The roles will focus on high-speed fill-finish environments (Virginia) and FDA 483 remediation, process risk analysis, and validation support (Delaware).Candidates must have strong hands-on experience in automated manufacturing environments, quality systems, and process improvement initiatives within regulated industries.Key ResponsibilitiesSupport automated manufacturing operations in pharma/medical device environmentsDevelop line layouts, fixture designs, and support 3D printing initiativesConduct detailed process risk assessments and update PFMEAsEvaluate and implement mitigation controls across manufacturing processesSupport validation activities including IQ, OQ, PQ, and TMVReview and update SOPs, Work Instructions, and DHF documentationEnsure alignment between documented procedures and actual production practicesDrive process improvements and remediation activitiesCollaborate with cross-functional teams (Manufacturing, Quality, Engineering)Support dimensional inspection, detection systems, capital equipment, and electromechanical assembliesRequired QualificationsBachelor’s degree in Mechanical or Manufacturing Engineering5–7 years of Manufacturing Engineering experience in FDA-regulated pharma or medical device environmentsPharmaceutical high-speed fill-finish experience (Required for Virginia role)Strong knowledge of Quality Management Systems (QMS)Hands-on experience with PFMEA, process risk analysis, and validationExperience in automated manufacturing environmentsProficiency in AutoCAD and SolidWorksBasic understanding of PLCs and HMIsExperience managing small-to-mid scale engineering projectsPreferred QualificationsExperience with filling and capping equipmentPrior FDA inspection or 483 remediation experienceBackground in capital equipment or electromechanical product manufacturingRecruiter | S4 AnalyticsPlease feel free to reach me at + 1(469)-429-8065Pavan@s4analytix.com