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.
