Provides Company owner-side project-engineering support to the Process Lead during the Buffer Prep / Buffer Hold (BPBH) brownfield expansion within an active 24/7 GMP facility.
Acts as owner's representative for the process equipment installation package - coordinating and overseeing the General Contractor's (GC) execution, owning field-level permit-to-work, walkdowns, safety, and coordination, and supporting the Process Lead in reviewing the A/E's process design.
Design authority and responsibility rest with the Process Lead and the A/E; this role actively supports design review and owns owner-side execution oversight.
The incumbent supports the Lead, owns the owner-side coordination of the process package, and develops process-engineering expertise through the project.
Responsibilities
Serves as Company's owner-side representative for the process equipment package (tanks, skids, heat exchangers, transfer panels/manifolds, CIP/SIP) during brownfield construction; provides day-to-day oversight of the General Contractor (GC) and its subcontractors for this scope, monitoring progress, quality, and compliance against the approved design.
Owns permit-to-work (PTW) coordination and issuance for process construction activities within the active 24/7 GMP facility; enforces construction segregation from live manufacturing and coordinates tie-ins/shutdown windows with site operations.
Conducts and participates in field walkdowns, inspections, and punch-list development for the process equipment and process-mechanical scope; verifies installed work matches design and site standards before turnover.
Supports construction safety: participates in contractor safety evaluations, supports the site safety plan for process activities, and ensures GC adherence to Company EHS requirements on an active manufacturing site.
Acts as liaison and coordination point between the GC, the A/E (Fluor), site operations, and the Process Lead; ensures construction activities do not negatively impact ongoing production.
Supports the Process Lead in reviewing A/E design deliverables (drawings, specifications, P&IDs, process control narratives); reviews GC submittals and RFIs for alignment with Company standards. (Design review and support role - design authority and responsibility rest with the Process Lead and the A/E.)
Maintains as-built documentation and field records for the process equipment and process-mechanical package; tracks open items, field issues, and schedule for the scope and escalates to the Process Lead.
Supports commissioning, turnover, and startup for the process equipment and process-mechanical package; assists the Lead and CQV team with field troubleshooting and system handover to operations.
Supports the Process Lead during vendor process-equipment installation (buffer tanks, process skids, heat exchangers (HEX), transfer panels, CIP tie-ins); coordinates GC mechanical/process installation and witnesses field activities.
Supports FAT/SAT and process commissioning activities; assists with field data collection and troubleshooting of newly installed process systems.
Qualifications / Requirements
Bachelor's degree in Chemical, Biomedical, or Mechanical Engineering.
3-7 years of experience in pharmaceutical/biotech or industrial capital projects, ideally in an owner's-representative or GC/EPC field-engineering capacity.
Biotechnology experience required.
Experience with brownfield construction in an operating facility: permit-to-work systems, field walkdowns, construction safety, and contractor coordination.
Working familiarity with biologics process systems - buffer prep/hold tanks, process skids, heat exchangers (HEX), transfer panels/manifolds, CIP/SIP tie-ins, and hygienic process piping - sufficient to support the Lead and coordinate the GC (design-level mastery is not required at this level).
GMP awareness and the ability to coordinate work safely within an active 24/7 manufacturing environment.
Preferred:
Spanish fluency / bilingual (Puerto Rico site - strong advantage).
Construction management exposure or coursework; ability to read and interpret construction drawings and specifications.
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $53.72/hr.