Project Manager

Validation & Engineering Group, Inc. provides engineering, validation, and project management services to regulated industries. The Project Manager will lead capital projects and strategic initiatives in pharmaceutical and biotechnology manufacturing environments, managing delivery, budgets, schedules, risks, compliance, and cross-functional coordination through project closeout.

Responsibilities:

• Lead overall project delivery, governance, and execution throughout the project lifecycle
• Develop and maintain project plans, schedules, budgets, forecasts, resource strategies, and risk management plans
• Coordinate cross-functional teams to ensure projects are delivered safely, on schedule, within budget, and in compliance with applicable GMP and site requirements
• Handle project financial performance including cost tracking, forecasting, variance analysis, and reporting
• Support procurement coordination, contractor management, vendor management, and technical alignment activities
• Lead project meetings and communicate project status, risks, issues, mitigation plans, and key decisions to stakeholders and leadership teams
• Coordinate project scope changes, project documentation, and project-related change activities as required
• Prepare and maintain project documentation including schedules, status reports, risk logs, budgets, meeting minutes, action trackers, and project closeout packages
• Coordinate activities supporting commissioning, qualification, startup, operational readiness, and turnover to operations
• Support project execution activities in alignment with applicable EHSS requirements and site procedures
• Identify project risks, resource constraints, and execution challenges while driving timely resolution and escalation when needed
• Support continuous improvement initiatives related to project execution, compliance, and operational performance

Requirements:

• Bachelor's degree in Engineering required
• Minimum of 8 years of experience managing capital projects within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries
• Demonstrated experience supporting manufacturing, packaging, facilities, utilities, process equipment, cleanroom environments, and regulated operational systems
• Proven experience managing project scope, schedule, budget, risks, stakeholder communications, and cross-functional coordination
• Experience supporting projects through design, procurement, construction, commissioning, startup, qualification, and operational handover phases
• Experience coordinating with engineering firms, contractors, equipment vendors, and internal technical teams
• Strong understanding of GMP environments, regulated project execution, and quality system expectations
• Excellent verbal and written communication skills in both English and Spanish, including technical writing, documentation preparation, meeting facilitation, and communication of project deliverables
• Strong leadership, organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and complex project portfolios
• Ability to work effectively within fast-paced and highly regulated environments
• Familiarity with project management, scheduling, cost tracking, and reporting tools such as MS Project, SAP, Planisware, Primavera, or similar systems is preferred
• PMP certification is preferred