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LL01-251006 Project Manager for Biotech Site

LL01-251006 Project Manager for Biotech Site

Validation & Engineering GroupHolly Springs, NC, US
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Project Manager Biotech Manufacturing Projects

The Project Manager will oversee the planning, design, installation and start-up of biotechnology manufacturing facilities and / or process systems. This role ensures successful delivery of cGMP-compliant production suites, clean utilities, process equipment, and supporting infrastructure, coordinating multidisciplinary teams from concept through operational readiness. The PM will manage cost, schedule, risk, and quality while maintaining strict compliance with regulatory standards and site safety policies.

Key Responsibilities

  • Lead all phases of biotech manufacturing projects : concept, basic / detailed design, procurement, construction, installation, commissioning, qualification, and turnover.
  • Develop Project Execution Plans (PEP), project charters, detailed work-breakdown structures (WBS), integrated master schedules, and resource-loading plans.
  • Ensure alignment with User Requirements Specifications (URS), Basis of Design (BOD), and manufacturing / operational needs.
  • Coordinate construction of cleanrooms, classified areas (ISO 5-8), supporting clean utilities (WFI, clean steam, compressed air, gases), HVAC / BAS, and process automation.

Budget, Schedule & Cost Control

  • Develop and manage budget, forecasts, contingency, and cash flow.
  • Manage bids, vendor selection, purchase orders, change orders, and invoice approvals.
  • Prepare weekly and monthly progress reports for senior management and client stakeholders.

    • Quality, Compliance & Risk

  • Ensure all construction and start-up activities meet FDA / EMA cGMP, ISO, and corporate quality standards.
  • Support risk-based CQV strategies aligned with ASTM E2500 and ISPE Baseline Guides.
  • Oversee FAT / SAT, equipment installation verification, and coordination with CQV and QA / QC teams.
  • Manage project risk register, mitigation plans, and change-control processes.

    • Stakeholder & Team Leadership

  • Act as primary interface with the client, engineering firms, EPCM contractors, OEM vendors, site operations, and regulatory authorities.
  • Facilitate design reviews, constructability assessments, HAZOP / FMEA workshops, and turnover planning sessions.
  • Lead cross-functional meetings (engineering, construction, procurement, CQV, operations) and resolve technical or contractual issues.
  • Promote a strong safety culture and adherence to EHS policies during all phases.

    • Operational Readiness & Turnover

  • Support start-up and operational readiness plans, including staff training, SOP coordination, and spare-parts strategies.
  • Deliver turnover packages, as-built documentation, and regulatory-ready validation packages to manufacturing operations.
  • Ensure project close-out with lessons learned and warranty tracking.

    • Required Qualifications

  • Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Industrial, or related discipline).
  • 5+ years of progressive project management experience in biotech / pharmaceutical manufacturing facilities, including capital project delivery.
  • Demonstrated expertise with cleanroom construction, process equipment installation (bioreactors, isolators, filling lines), clean utilities (WFI, PW, CS, gases), and automation / BMS.
  • Strong understanding of cGMP, FDA / EMA regulations, ISPE / GAMP 5, ASTM E2500.
  • Proficiency in MS Project, Primavera P6, Smartsheet, or equivalent scheduling tools.
  • Excellent leadership, negotiation, and stakeholder-management skills.

    • Preferred / Desirable

  • PMP or equivalent project management certification.
  • Experience in single-use systems, cell & gene therapy, aseptic processing, and high-potency API containment.
  • Familiarity with LEED commissioning (Fundamental, Enhanced, Envelope) and sustainable facility practices.
  • Working knowledge of Procore, Kneat, Bluebeam, Autodesk ACC / BIM, SAP / Oracle ERP.
  • Bilingual English / Spanish highly desirable for Puerto Rico and LATAM projects.

    • Core Competencies

  • Strategic leadership of multi-million-dollar CAPEX programs.
  • Risk-based decision-making in highly regulated environments.
  • Strong interpersonal and communication skills to align diverse teams.
  • Commitment to EHS, quality, and schedule-driven execution.
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    Site Project Manager • Holly Springs, NC, US

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