Sterile Construction Project Manager

ELSEALLC|EmpoweringOwners

SterileConstructionProjectManager

PharmaceuticalSterileFacilityFitOut

TheOpportunity

El Sea LLC, an owner's representative and project management firm, is seeking an experienced Sterile Construction Project Manager to run construction management and cost controls on a sterile fit out project for a pharmaceutical manufacturing client. The engagement is a year in the Delaware area.Requires candidate to be on site full time.Theprojectteamruns lean: the successful candidate must bring the experience to hit the ground running with no ramp-up period.

Requirements

•Three to five years of project experience on projects with filling and process equipment; OSD packaging experience preferred

•On-site presence during active construction, equipment installation, utility tie-ins, testing, turnover, and startup

Process&MechanicalSystemsExpertise

•Processpipingbydivision:Div40processinterconnections,Div22plumbingandcleanutilities,Div23HVACandclean steam, Div 33 site utilities, Div 11 equipment, Div 13 cleanrooms and containment

•ASMEB31.3forprocesspipingandASMEBPEforproductcontact

•Welddocumentation:WPS,PQR,weldercontinuity,weldlogsandweldmaps,borescoperecords,MTRsandmaterialtraceability

•Systemtestingandacceptance:pressureandleaktesting,slopeanddrainability,passivation,flushandclean

•Cleanutilities:WFI,cleansteam,processgases,CIPandSIPdistribution

•Highcontainment:OEBbanding,isolatorandRABSinterfaces,containmentverification

•Buildingandprocesscontrols:BMS,EMS,processcontrols,alarms,interlocks,roompressuremonitoring,temperatureand humidity control, and integration with equipment vendors

•Filling,inspection,packaging,andmaterial-handlingequipmentinstallation:equipmentsetting,utilityconnections,vendor coordination, FAT/SAT follow-up, and readiness for commissioning

•OSDpackagingrequirements:dustcontrol,productsegregation,personnelandmaterialflows,lineclearance,packaging equipment interfaces, and serialization/aggregation infrastructure

Regulatory&Documentation• cGMPconstructionrequirementsper21CFR210/211andFDAsteriledrugproductguidance

•GoodDocumentationPractices:contemporaneous,attributable,legible,nobackfilling,nopencil,propererrorcorrection

•ALCOA+appliedtofieldrecords

•ConstructionturnoverintoCQV:systemboundaries,SystemTurnoverPackages,andhowafielddocumentationgap becomes a qualification delay

•Changeanddeviationcontrolduring

Cleanroom&OccupiedFacilityProtocols

•Cleanroomconstructionprotocols:gowning,materialairlocks,toolcontrol,temporarycontainment,ISOclassificationand hand-off of classified space

•Sequencingandcleanroom-safefinishes,penetrationsealing,ceilinggridintegrity

•Occupiedfacilitywork:permittowork,LOTO,hotwork,dustandnoisecontrol,utilitytie-inandshutdownplanning, segregation from GMP operations

•Contaminationcontrolplanningforconstructionadjacenttosterile,classified,oroperationalareas:pressurerelationships, temporary air handling, cleaning and release of work areas, and cross-contamination prevention

•Coordinationofroomcertification,HEPAintegritytesting,airbalancing,pressure-cascadeverification,recoverytesting,and environmental-monitoring readiness

CommercialOversight

•Developandmaintaintheconstructionschedule,includingcontractorsequencing,equipmentdeliveries,utilityavailability, commissioning, CQV turnover, and operational-readiness milestones

•Coordinatethegeneralcontractor,tradecontractors,designteam,equipmentvendors,CQV,Quality,Operations,EHS, IT/automation, and facility stakeholders

•Validatepayapplicationsagainstworkactuallyinstalled,notthescheduleofvalues

•Reviewprogressphotosandin-progressworkagainstspecs,drawings,andapprovedshopdrawings

•Manageshopdrawings,RFIs,submittals,procurementtracking,changeorderevaluations,scheduleimpacts,andcontractor recovery plans with technical judgment

•Identifyandescalatequality,cost,schedule,safety,andturnoverrisksbeforetheyaffectcommissioningorqualification

Expressinginterest:

Please send acurrentresumeandconfirmationoffull-timeavailability for an immediate start.