Project Executive (Life Sciences)

Responsibilities

• Oversee and direct construction projects from conception to completion.
• Work with customer’s representatives and general contractor to develop project execution strategy, logistics plans, and project-specific safety plans.
• Support clients in the project setup process; including construction contract reviews, staff plans, budgets, and project processes.
• Prepare construction budget based on scope of work and resource requirements. Track project costs to meet construction budget.
• Develop and manage a detailed project schedule and work plan.
• Perform periodic walkthroughs of the construction site and provide feedback to the general contractor and subcontractors.
• Develop and manage quality control, document control, and communication plans.
• Conduct thorough reviews of construction documents to ensure compliance with project scope, standards, and regulations.
• Manage the documentation process to maintain accuracy and consistency throughout the project lifecycle.
• Regularly monitor and track the status of capital projects, including budget, schedule, and quality performance.
• Prepare and present detailed project reports to senior leadership and stakeholders, including identifying risks and resolving project issues.
• Identify areas for improvement in program and project delivery. Develop and implement interventions to enhance efficiency, quality, and safety across all projects.
• Regularly contribute to strategic planning discussions, providing recommendations and insights to drive organizational success.
• Prepare comprehensive reports on project status, financial health, and overall performance.
• Manage contracts with contractors and consultants.
• Collaborate and build effective relationships with Client’s project team, owners and final users, design team, contractors, and local jurisdictional personnel.
• Manage cross-functional teams, build strong stakeholder relationships, and manage multiple high-priority projects simultaneously.
• Communicate data clearly and concisely to senior leaders and stakeholders.
• Experience working on regulated industries and knowledge of regulatory and compliance requirements: FDA regulations, Good Engineering Practices (GEP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP).
• Experience with the design, construction, commissioning, and operation of pharmaceutical, biotechnology, and/or general life sciences facilities and infrastructure.

Requirements

• 15-20 years of experience in managing complex life science capital projects, with demonstrated expertise in stakeholder management, strategic planning, and cross-functional leadership.
• Bachelor’s degree in engineering, construction management, facilities management, or a related technical field; or equivalent experience.
• Substantial experience with cGMP facility design, build, qualification, and maintenance.
• Experience with the design, construction, commissioning, and operation of pharmaceutical, biotechnology, and/or general life sciences facilities and infrastructure.
• Experienced leader, with knowledge of program management, project management, project controls, construction management, commissioning, and qualification services in regulated environments.
• Strong experience in project budgeting, scoping, and estimating, including managing capital project financials.
• Proven ability to lead cross-functional teams, build strong stakeholder relationships, and manage multiple high-priority projects simultaneously.
• Exceptional communication skills, both verbal and written, with an ability to present data clearly and concisely to senior leaders and stakeholders.
• Experience working on regulated industries and knowledge of regulatory and compliance requirements: FDA regulations, Good Engineering Practices (GEP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP).
• Familiarity with the Code of Federal Regulations (CFR) as related to cGMP in Manufacturing, Processing, Packaging, and Holding of Drugs and Finished Pharmaceuticals; Dietary Supplement & Human Food; Biological Products & General Biological Products Standards; Good Clinical Practices for Medical Devices; and Quality Systems Regulations.
• Previous project experience in one or more of the following technologies and platforms: manufacturing and utilities systems; clean and aseptic rooms; clean-in-place (CIP); steam-in-place (SIP); autoclaves; vapor hydrogen peroxide (VHP) sterilization; solid dose preparation areas; powder feeding and continuous manufacturing; blending, milling, granulation, and formulation; fermentation, purification, and conjugation processes; controlled temperature environments; injectables sterile fill and packaging facilities; conveyors and clean packaging automation; GMP warehousing; and, automated storage and retrieval warehouse systems.

Physical and Other Requirements

• The job requires both office and site-based work, including travel to job sites in various weather conditions.
• On-site safety gear (e.g., hard hat, glasses, safety harness) is required.
• Ability to traverse construction sites and perform inspections in various weather conditions.
• May involve lifting up to 30 lbs. (13.6 kg) and extended periods of sitting or using office equipment.
• May require travel.
• Must have valid driver’s license.

Benefits

• 35k 401k with 3% employer contribution
• Cell phone allowance
• Employer paid life insurance and long-term disability
• Full medical, dental, and vision benefits
• Paid time-off and holidays