Inteldot Logo

Inteldot

Project Manager

Posted 16 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in Gurabo
Senior level
Remote
Hiring Remotely in Gurabo
Senior level
Lead planning, execution, control, and closeout of capital and regulatory projects in a pharmaceutical manufacturing environment. Manage schedules, budgets, risks, cross-functional teams, change control, and compliance with GMP, EHSS, FDA/EMA standards. Drive stakeholder communication, issue escalation, and project documentation including validation and lessons learned.
The summary above was generated by AI

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Employment type: Full time and onsite role

Role Summary
The Project Manager is responsible for leading the planning, execution, control, and closeout of capital projects, process improvements, facility expansions, validation initiatives, and other regulated projects within a pharmaceutical manufacturing environment. This role ensures projects are delivered safely, on schedule, within budget, and in compliance with EHSS, quality, regulatory, and company standards.
Key Responsibilities

• Lead overall project delivery, governance, and execution across low, moderate, and high-complexity projects.
• Develop and maintain project plans, schedules, budgets, risk registers, and communication plans.
• Coordinate cross-functional teams supporting engineering, manufacturing, packaging, and operations functions.
• Facilitate project meetings, monitor progress, and communicate status to stakeholders.
• Manage project scope, risks, issues, and change control activities.
• Ensure compliance with GMP, EHSS, FDA, EMA, and applicable regulatory requirements.
• Escalate unresolved issues and drive timely decision-making.
• Support project closeout activities, including documentation and lessons learned.
Requirements & Qualifications

• Bachelor's degree in engineering.
8+ years of project management experience in pharmaceutical, biotechnology, medical device, or other regulated industries.
• Experience managing capital projects, process improvement initiatives, facility upgrades, or validation projects.
• Knowledge of GMP, regulatory compliance, and pharmaceutical manufacturing environments.
• Strong leadership, communication, stakeholder management, and problem-solving skills.
• Proficiency with project planning and scheduling tools.
• Bilingual (Spanish and English)
Preferred Qualifications

• PMP, PRINCE2, or equivalent project management certification.
• Experience supporting manufacturing operations, packaging, synthetics, or biotherapeutics facilities.
• Familiarity with project portfolio management and stage-gate project delivery methodologies.

    Similar Jobs

    19 Days Ago
    In-Office or Remote
    49 Locations
    95K-176K Annually
    Mid level
    95K-176K Annually
    Mid level
    Healthtech • Biotech • Pharmaceutical
    Lead sponsor-dedicated biomarker study operations across phases 1-4, coordinating cross-functional teams, vendors, and sample logistics. Manage project delivery (timelines, budget, scope), maintain TMF and study systems, ensure regulatory compliance and inspection readiness, prepare reports, and proactively mitigate operational risks. Support bioanalytical strategy, specimen collection/tracking/analysis, and stakeholder communication.
    5 Days Ago
    Remote
    Senior level
    Senior level
    Professional Services • Biotech • Consulting • Pharmaceutical
    Lead and deliver multiple complex projects from initiation to close, focusing on manual production line operations, validation, and technology implementations. Develop plans, budgets, and timelines; manage risks; coordinate cross-functional teams and stakeholders; ensure compliance, quality, and alignment with business objectives.
    6 Days Ago
    Remote
    Senior level
    Senior level
    Real Estate • Financial Services
    Lead site-based project delivery at the Gurabo manufacturing site, managing a portfolio of capital, facilities, compliance, safety, and operational projects. Serve as primary client liaison, lead JLL project team, oversee planning/execution/reporting, track KPIs, mitigate risks, run governance meetings, and ensure timely closeout with documentation and financial reconciliation.

    What you need to know about the Seattle Tech Scene

    Home to tech titans like Microsoft and Amazon, Seattle punches far above its weight in innovation. But its surrounding mountains, sprinkled with world-famous hiking trails and climbing routes, make the city a destination for outdoorsy types as well. Established as a logging town before shifting to shipbuilding and logistics, the Emerald City is now known for its contributions to aerospace, software, biotech and cloud computing. And its status as a thriving tech ecosystem is attracting out-of-town companies looking to establish new tech and engineering hubs.

    Key Facts About Seattle Tech

    • Number of Tech Workers: 287,000; 13% of overall workforce (2024 CompTIA survey)
    • Major Tech Employers: Amazon, Microsoft, Meta, Google
    • Key Industries: Artificial intelligence, cloud computing, software, biotechnology, game development
    • Funding Landscape: $3.1 billion in venture capital funding in 2024 (Pitchbook)
    • Notable Investors: Madrona, Fuse, Tola, Maveron
    • Research Centers and Universities: University of Washington, Seattle University, Seattle Pacific University, Allen Institute for Brain Science, Bill & Melinda Gates Foundation, Seattle Children’s Research Institute

    Sign up now Access later

    Create Free Account

    Please log in or sign up to report this job.

    Create Free Account