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Senior Project Manager (Pharma Capital Projects)

Manati, PR · Manufacturing

Summary

We are seeking a Senior Project Manager to lead pharma capital projects with emphasis on construction, process equipment installation, and utilities (HVAC, Purified Water/WFI, Clean Steam, Compressed Air, gases, power). This role owns the full project lifecycle—from concept and design through construction, commissioning, qualification, and handover—ensuring adherence to cGMP, EHS, and corporate standards.

Responsibilities

  • Lead end-to-end project management (scope, schedule, cost, quality, risk, communications, procurement).

  • Build and maintain master schedules (MS Project / Primavera P6); set milestones, critical path, and recovery plans.

  • Manage budgets, cash flow, and cost control (forecast, EAC, change control).

  • Coordinate process, mechanical, electrical, civil/structural engineering and architecture; ensure delivery of design packages (URS, P&IDs, layouts, specifications).

  • Direct field execution: construction, installation, start-up of manufacturing equipment (mixers, reactors, lyophilizers, packaging, automation) and utility systems (HVAC, WFI, clean steam, CDA, nitrogen, substations).

  • Manage contractors/EPCs and suppliers (RFPs/bids, POs, submittals, RFIs, construction quality, safety).

  • Ensure Commissioning & Qualification (CQV) with QA/Validation: FAT/SAT, IQ/OQ/PQ, TMV, and deviation closure.

  • Drive risk management (registers/mitigations), formal change control, and project governance.

  • Maintain compliance documentation (cGMP, EHS/OSHA), permits, redlines/as-builts, and turnover dossier.

  • Report progress to stakeholders with weekly/monthly updates and KPIs (cost, schedule, safety, quality).

Requirements

  • B.S. in Engineering (Industrial, Mechanical, Electrical, Chemical or related).

  • 10+ years leading pharma capital projects involving construction, equipment, and utilities.

  • Hands-on, on-the-floor problem solving in manufacturing areas, facilities, equipment, and utilities.

  • Proficiency with MS Project or Primavera P6, cost control (EVM preferred), and contract management.

  • Working knowledge of cGMP, electrical codes, ASME/BPE, SMACNA, ISPE Baseline Guides, and EHS practices.

  • Strong leadership of multidisciplinary teams and multiple contractors in an active site.

  • Bilingual (English/Spanish) with executive-level written and verbal communication.

Preferred

  • Current PMP.

  • Experience in aseptic/cleanroom environments (ISO classifications, differential pressure, EM).

  • Familiarity with automation/controls (PLC/SCADA/BMS/BAS) and integration with qualification.

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