Project Manager

LaSalle Group is a boutique consulting firm working with top global life sciences companies, delivering management, operations, quality & regulatory compliance, and talent development solutions. We operate out of our Raleigh-Durham and San Juan offices. What You'll Do As a Project Manager, you'll lead capital and operational engineering projects within a cGMP-regulated solid dosage form (SDF) pharmaceutical manufacturing facility, ensuring initiatives supporting production continuity, capacity expansion, and equipment qualification are delivered on schedule, within budget, and in full compliance with FDA, EMA, and internal quality requirements. Key Responsibilities Serve as the primary point of accountability for assigned engineering projects, from initiation through closeout. Plan, execute, monitor, and close engineering and capital projects, including equipment installation, commissioning, and qualification (IQ/OQ/PQ). Develop and maintain integrated project plans, schedules, budgets, and resource allocation aligned with PMI/PMBOK methodology. Coordinate validation and change control activities in partnership with Quality Assurance and Validation Engineering teams. Facilitate project governance, including steering committee updates, stage-gate reviews, and change control board participation. Ensure all deliverables comply with applicable regulatory requirements (FDA 21 CFR Part 210/211, cGMP, EHS standards). What We're Looking For Required Bachelor's degree in Industrial Engineering, Mechanical Engineering, or a related discipline. Active PMP® (Project Management Professional) certification from PMI, or in active pursuit. 5–7 years of project management experience in pharmaceutical, biotech, or life sciences manufacturing. Experience with equipment qualification (IQ/OQ/PQ), validation lifecycle, and change control processes. Proficiency with project management tools (MS Project, Primavera P6, Smartsheet) and PMI/PMBOK-based methodologies. Professional English proficiency; Spanish preferred for Puerto Rico-based facilities. Familiarity with FDA cGMP regulations (21 CFR Parts 210/211), EHS requirements, and quality systems (e.g., TrackWise, Veeva). Strong stakeholder management and cross-functional leadership across Engineering, Quality, and Operations. Bilingual (English/Spanish). Preferred Advanced degree in Engineering or a related field #J-18808-Ljbffr LaSalle Group, LLC