El Sea

EL SEA LLC | Empowering Owners

Sterile Construction Project Manager

Pharmaceutical Sterile Facility Fit Out

The Opportunity                                                                                                                                       

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. The project team runs 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 & Mechanical Systems Expertise            

•      Process piping by division: Div 40 process interconnections, Div 22 plumbing and clean utilities, Div 23 HVAC and clean steam, Div 33 site utilities, Div 11 equipment, Div 13 cleanrooms and containment

•      ASME B31.3 for process piping and ASME BPE for product contact

•      Weld documentation: WPS, PQR, welder continuity, weld logs and weld maps, borescope records, MTRs and material traceability

•      System testing and acceptance: pressure and leak testing, slope and drainability, passivation, flush and clean

•      Clean utilities: WFI, clean steam, process gases, CIP and SIP distribution

•      High containment: OEB banding, isolator and RABS interfaces, containment verification

•      Building and process controls: BMS, EMS, process controls, alarms, interlocks, room pressure monitoring, temperature and humidity control, and integration with equipment vendors

•      Filling, inspection, packaging, and material-handling equipment installation: equipment setting, utility connections, vendor coordination, FAT/SAT follow-up, and readiness for commissioning

•      OSD packaging requirements: dust control, product segregation, personnel and material flows, line clearance, packaging equipment interfaces, and serialization/aggregation infrastructure

Regulatory & Documentation                                                                                                                         •     cGMP construction requirements per 21 CFR 210/211 and FDA sterile drug product guidance

•      Good Documentation Practices: contemporaneous, attributable, legible, no backfilling, no pencil, proper error correction

•      ALCOA+ applied to field records

•      Construction turnover into CQV: system boundaries, System Turnover Packages, and how a field documentation gap becomes a qualification delay

•      Change and deviation control during 

Cleanroom & Occupied Facility Protocols                               

•      Cleanroom construction protocols: gowning, material airlocks, tool control, temporary containment, ISO classification and hand-off of classified space

•      Sequencing and cleanroom-safe finishes, penetration sealing, ceiling grid integrity

•      Occupied facility work: permit to work, LOTO, hot work, dust and noise control, utility tie-in and shutdown planning, segregation from GMP operations

•      Contamination control planning for construction adjacent to sterile, classified, or operational areas: pressure relationships, temporary air handling, cleaning and release of work areas, and cross-contamination prevention

•      Coordination of room certification, HEPA integrity testing, air balancing, pressure-cascade verification, recovery testing, and environmental-monitoring readiness

Commercial Oversight

•      Develop and maintain the construction schedule, including contractor sequencing, equipment deliveries, utility availability, commissioning, CQV turnover, and operational-readiness milestones

•      Coordinate the general contractor, trade contractors, design team, equipment vendors, CQV, Quality, Operations, EHS, IT/automation, and facility stakeholders

•      Validate pay applications against work actually installed, not the schedule of values

•      Review progress photos and in-progress work against specs, drawings, and approved shop drawings

•      Manage shop drawings, RFIs, submittals, procurement tracking, change order evaluations, schedule impacts, and contractor recovery plans with technical judgment

•      Identify and escalate quality, cost, schedule, safety, and turnover risks before they affect commissioning or qualification

Expressing interest: 

Please send a current resume and confirmation of full-time availability for an immediate start.