Talent.com
LL01-251006 Project Manager for Biotech Site

LL01-251006 Project Manager for Biotech Site

Validation & Engineering GroupHolly Springs, NC, US
7 days ago
Job type
  • Full-time
Job description

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.
  • Create a job alert for this search

    Site Project Manager • Holly Springs, NC, US

    Related jobs
    • Promoted
    Project Director - Precision Medicine (US)

    Project Director - Precision Medicine (US)

    AlimentivMorrisville, NC, US
    Full-time
    Project Director - Precision Medicine (US).San Diego, California / Atlanta, Georgia / Austin, Texas / Baltimore, Maryland / Cincinatti, Ohio / Columbus, Ohio / Chicago, Illinois / Tampa Bay, Florid...Show moreLast updated: 19 days ago
    • Promoted
    Project Manager - Life Sciences

    Project Manager - Life Sciences

    DPR ConstructionMorrisville, NC, US
    Full-time
    DPR Construction is seeking a Life Sciences project manager with a minimum of 5 years of commercial construction experience. This individual will be ultimately responsible for the day-to-day executi...Show moreLast updated: 30+ days ago
    • Promoted
    R&D Project Manager

    R&D Project Manager

    ABBMebane, NC, US
    Full-time
    At ABB, we help industries outrun - leaner and cleaner.Here, progress is an expectation - for you, your team, and the world. As a global market leader, we'll give you what you need to make it happen...Show moreLast updated: 30+ days ago
    • Promoted
    Manager, Formulation Development

    Manager, Formulation Development

    IndiviorRaleigh, NC, US
    Full-time
    Manager, Formulation Development.Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD).Our vision is that all...Show moreLast updated: 24 days ago
    • Promoted
    Supervisor, Quality Control Microbiology

    Supervisor, Quality Control Microbiology

    NovartisDurham, NC, US
    Full-time
    This position will supervise a team within the Quality Control Microbiology department.The supervisor will coordinate sample throughput and compliance activities within the Quality department as we...Show moreLast updated: 27 days ago
    • Promoted
    Project Manager - Data Quality and MDM

    Project Manager - Data Quality and MDM

    OnticCreedmoor, NC, US
    Full-time
    Project Manager Data Quality & MDM.Ontic is a leading global aerospace OEM trusted by the world's aviation leaders.Ontic's Chatsworth, CA, site specializes in precision engineering, MRO, and new s...Show moreLast updated: 30+ days ago
    • Promoted
    Manager, QC Lab Support

    Manager, QC Lab Support

    FUJIFILMHolly Springs, NC, US
    Full-time
    The Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product.This role appl...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Research Administrator

    Senior Research Administrator

    InsideHigherEdRaleigh, North Carolina, United States
    Full-time +2
    The College of Natural Resources is a world leader in the sustainability and stewardship of the planet we share.Across a broad array of programs, we supply students with the technical expertise and...Show moreLast updated: 5 days ago
    • Promoted
    Sr Regulatory Affairs Specialist

    Sr Regulatory Affairs Specialist

    TeleflexRaleigh, NC, US
    Full-time
    Sr Regulatory Affairs Specialist.Teleflex is investing in our capability to drive material cost improvement opportunities as part of a strategic corporate approach to reversing recent trends in cos...Show moreLast updated: 30+ days ago
    • Promoted
    Laboratory Manager

    Laboratory Manager

    InsideHigherEdRaleigh, North Carolina, United States
    Full-time +2
    The lab manager is expected to conduct at least two of the following tasks : 1) conduct biomechanical analysis using motion capture systems and force plates. 2) conduct and coordinate clinical studi...Show moreLast updated: 3 days ago
    • Promoted
    Quality Analyst SR

    Quality Analyst SR

    StaffingRaleigh, NC, US
    Full-time
    Associate Director, Quality Assurance.Monday to Friday, from 8 : 00 to 5 : 00, three days a week in the Raleigh office.The Associate Director, Quality Assurance, is responsible for the global strategic...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Quality Program Manager

    Clinical Quality Program Manager

    Elevance HealthDurham, NC, US
    Full-time
    Clinical Quality Program Manager.We are partnering with North Carolina DHHS to operationalize a statewide Medicaid Plan designed to support Medicaid-enrolled infants, children, youth, young adults,...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Product Quality AssuranceDurham, NC

    Director, Product Quality AssuranceDurham, NC

    Beam TherapeuticsDurham, NC, US
    Full-time
    Interested in building your career at Beam Therapeutics? Get future opportunities sent straight to your email.We are a federal contractor or subcontractor. The law requires us to provide equal emplo...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Laboratory Team Lead - DNA

    Clinical Laboratory Team Lead - DNA

    LabcorpBurlington, NC, US
    Full-time +1
    Are you an experienced clinical laboratory professional looking for a leadership opportunity? Are you detail oriented, process focused, and enjoy leading others? Are you looking for an industry lea...Show moreLast updated: 1 day ago
    • Promoted
    R&D Manager

    R&D Manager

    FreudenbergDurham, NC, US
    Full-time
    Product & Process Development : Responsible for designing, improving, and maintaining new and existing products and processes that are cost-efficient, manufacturable, and reliable.Market Research : R...Show moreLast updated: 12 days ago
    • Promoted
    Research Operations Manager - Horticulture Field Lab

    Research Operations Manager - Horticulture Field Lab

    NC State UniversityRaleigh, NC, United States
    Full-time +1
    Research Operations Manager - Horticulture Field Lab.Monday - Friday; 8AM-5PM hours may vary, some weekends possible.The Horticulture Field Laboratories at NC State University are living classrooms...Show moreLast updated: 30+ days ago
    • Promoted
    UTS - Temporary Clinical Research Manager at UNC Chapel Hill

    UTS - Temporary Clinical Research Manager at UNC Chapel Hill

    InsideHigherEdRaleigh, North Carolina, United States
    Full-time +2
    The department has two overarching goals.The first goal is to increase understanding of how adverse posttraumatic neuropsychiatric sequelae (e. The second goal is to use this knowledge to develop an...Show moreLast updated: 3 days ago
    • Promoted
    Sr Study Start Up Lead

    Sr Study Start Up Lead

    ProPharma GroupRaleigh, NC, US
    Full-time
    ProPharma Group Job Opportunity.For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceut...Show moreLast updated: 30+ days ago