Project Manager

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.