Upstream Process Engineer

Technical Source is seeking experienced Upstream Process Equipment Engineers to support a large-scale biologics manufacturing expansion project in Holly Springs, NC. This role will support startup, commissioning, qualification, and operational readiness activities for upstream manufacturing systems within a GMP biologics environment.Opportunities include both supporting existing manufacturing operations as well as expansion efforts tied to new large-scale manufacturing facilities.This is a highly visible, hands-on engineering role supporting critical biologics manufacturing operations from equipment turnover through commercial production.ResponsibilitiesServe as equipment owner/work package owner for upstream process equipment systemsSupport startup, commissioning, qualification, and operational readiness activitiesPerform P&ID walkdowns, redlines, and mechanical completion verificationConduct and participate in FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing)Support CQV (Commissioning, Qualification, and Validation) activitiesInterface with vendors, contractors, and cross-functional project teamsReview equipment submittals and piping specificationsProvide troubleshooting support during engineering runs, PPQ (Process Performance Qualification), and commercial manufacturing campaignsSupport campaign changeovers and operational readiness activitiesParticipate in investigations, deviations, CAPA development, and change control activitiesSupport risk assessments related to equipment and process changesAssist with LOTO (Lock Out Tag Out) identification and procedure supportParticipate in 3D model reviews using Navisworks or similar toolsEquipment & Process ExperienceRequired Qualifications5+ years of experience in biopharma or biologics process/equipment engineeringStrong upstream process equipment experience within GMP manufacturing environmentsExperience owning equipment through startup, commissioning, CQV, and operational supportHands-on field execution experience including:P&ID walkdownsMechanical completion verificationFAT/SAT participationStartup troubleshootingExperience with GMP investigations, deviations, CAPA, and change controlFamiliarity with risk assessments and equipment troubleshootingStrong knowledge of stainless steel process equipment and upstream operationsExperience reviewing piping specifications and vendor documentationPreferred QualificationsExperience supporting large-scale biologics or mAbs manufacturing facilitiesNavisworks or other 3D model review experienceExperience developing or supporting LOTO proceduresExperience with major upstream equipment OEMsAdditional InformationMulti-year project with long-term stability through early 2028Opportunity to support a major biologics manufacturing expansionHigh-impact engineering role with direct involvement in startup and commercial operationsCompetitive compensation available based on experienceSome off-hours or weekend support may be required during critical startup and CQV phases